Category: Pharmaceutical

FDA Updates Supply Chain Security Guidance

Posted on by Brandon Miller

The U.S. Food and Drug Administration (FDA) recently published multiple new guidance documents to help accelerate supply chain security and new product tracing requirements in the pharmaceutical industry. While most countries have implemented firmer regulations over the last decade, this new guidance is timely as domestic industry executives are reexamining security protocols in the wake of prominent cyberattacks.

 

The Drug Supply Chain Security Act (DSCSA) was originally designed as a framework for manufacturers, wholesalers, and dispensers to comply with laws that accomplish a safer, secure, and entrusted drug supply chain. A primary objective of DSCSA is to develop models and strategies to reduce the distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs. These new FDA guidances include protocols for developing data architecture systems and how industry executives can optimize interoperability during the design and build phase. 

 

Need help with your Supply Chain? Talk to our Experts →

 

Drug Packaging

 

As part of the DSCSA, pharmaceutical manufacturers and repackagers are required to add a product identifier on drug packaging. The product identifier includes the product national drug code (NDC), serial number, lot number and expiration date for each package. It must be in both human- and machine-readable form (e.g. two-dimensional data matrix barcode). This is designed to help downstream partners (e.g. repackagers, wholesale distributors, and dispensers) associate the information encoded in the barcode with readable text used by Logistics teams. The updated human-readable format includes:

 

  • NDC: [insert product’s NDC]
  • SERIAL: [insert product’s serial number]
  • LOT: [insert product’s lot number]
  • EXP: [insert product’s expiration date]

 

Expiration Date

 

For select products where an expiration date includes only year and month due to space limitations, the drug’s actual expiration date is recommended to be the last day of the calendar month included in the human-readable expiration date on the drug package label.

 

Product Identifier

 

Each finished or unfinished drug is subject to regulatory listing requirements. The product identifier is a standardized graphic composed of an alphanumeric serial number (up to 20 characters) that helps identify the product and package configuration. Product identifiers must be affixed or imprinted on the smallest individual saleable unit of a product, which also includes all product sold to a dispenser.

 

National Drug Code

 

Each product identifier has a unique NDC. The NDC is a FDA-assigned 3-segment format (10 or 11-digit number) to identify its labeler, product, and package size and type. In select instances, the linear barcode requirements from 21 CFR 181 201.25 will stay in effect for additional FDA-regulated products and packaging. This digital fingerprint of data will be used to accelerate the regulatory learning process. 

 

Suspect/Illegitimate Products

 

The revised FDA guidance documents also now provide increased clarity regarding the FDA’s current interpretation of “suspect” and “illegitimate” products. “Suspect” and “illegitimate” products are defined as:

 

  • “counterfeit”
  • “diverted”
  • “stolen”
  • “fraudulent transaction”
  • “unfit for distribution”

 

Artificial Intelligence

 

As artificial intelligence and machine learning modernize the supply chain over time, it’s not unreasonable to imagine the new bar codes could detect medication errors in real time for healthcare professionals and pharmacists. This could provide alerts to validate industry professionals are:

 

  • Giving the right drug,
  • Via the right dose,
  • Via the right route of administration,
  • To the right patient,
  • At the right time.

 

Regulatory Agency Response

 

Specific scenarios designed for risk management of a suspect product entering the pharmaceutical supply chain are also referenced. The guidance provides examples of when manufacturers should notify the FDA of a high risk product that may be or is illegitimate. Industry executives are also encouraged to collaborate with the Agency to help refine existing processes for terminating notifications.

 

This new clarity provides pharmaceutical executives a further glimpse into the FDA’s interpretation of system attributes necessary for secure product tracing inside the marketplace. The language is noticeably more detailed at the package level and provides supporting commentary for avoiding supply chain disruptions and enhanced drug distribution security.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups looking for FDA guidance support. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement and FDA guidance. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

fda guidanceRegulatory Compliance Associates® (RCA) provides FDA guidance consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

FDA Expands Virtual Audit Guidance

Posted on by Brandon Miller

The US Food and Drug Administration (FDA) has recently expanded on its clarification of a virtual audit, and how new manufacturing protocols in the COVID-19 environment will evolve. Travel constraints continue to impact the industry, especially in countries like India where a tremendous outbreak of COVID cases erupted in April 2021.

 

“This does show that indeed, we are very much interested in doing these remote interactive investigations, you know, especially the ones with video streaming technology.” said Michael Kopcha, director of the Office of Pharmaceutical Quality in the agency’s Center for Drug Evaluation and Research.

Looking for help preparing for the new guidance? Contact Us Now →

After reviewing recommendations from the European Medicines Agency (EMA) and the UK Medicines and Healthcare Regulatory products Agency (UK MHRA), the FDA continues to address the questions many pharmaceutical companies and partners have voiced during the pandemic. FDA officials commented that, due to these early learnings from other global regulatory bodies, they have recently expanded their recommendations for virtual audit best practices and new criteria of considering when to conduct a remote inspection.

 

Two of the initial primary use cases for virtual pharmaceutical inspections mentioned by the FDA include records requests and on-site inspectional work. While developing the new virtual audit process is still ongoing, one recommendation is Pharmaceutical companies should choose a proven regulatory partner to assist with the audit. Agency executives explained they will not be engaging vendors to perform virtual audits on behalf of the FDA.

virtual audit

 

One looming issue to be remedied is will virtual audits be allowed for facilities with serious good manufacturing practice (GMP) violations. FDA officials have expanded on their risk-based approach to prioritization in deciding which sites may qualify. An expanded virtual audit strategy continues to be a work-in-progress by agency officials including defining which companies qualify for an FDA virtual inspection and, more importantly, in what order the virtual audits may happen.

 

GMP violations involve either FDA warning letters or action-indicated site classifications based on the possible corrective actions needed. If the corrective actions needed for a facility can be successfully addressed remotely, it may become more likely that the number of hybrid virtual inspections authorized by the FDA will continue to grow. However, agency official commentary concluded that each facility will be examined by the FDA team on an individual basis with consideration of potential violations involved being a primary decision-making driver.

 

The good news for Pharmaceutical industry executives is it appears the FDA is willing to learn from international regulatory experiences and potentially even collaborate using technology in new ways to increase the FDA’s ability to continue operations. Global travel limitations will more than likely impact every industry for the foreseeable future in 2021 until the COVID-19 vaccine becomes more widely administered.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharma consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance experience. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Compliance Enforcement
  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates pharmaceutical industry consultants are quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support

 

Remediation Services 

 

Regulatory Compliance Associates has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues.

 

In addition, each Regulatory Compliance Associates pharmaceutical industry consultant understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

Best Practices for FDA Inspections

Posted on by Brandon Miller

Since the Pandemic became global in 2020, the FDA has been requesting documents from firms in advance of or in lieu of an inspection. This authority comes from the Federal Food, Drug, and Cosmetic Act (FD&C Act) in Section 704(a)(4). However, while they have not adopted doing FDA inspections remotely instead of an onsite inspection, they have stated publicly they are considering the possibility, and virtual audits have become very common. 

 

FDA is still conducting onsite inspections and has submitted for new employee headcount in 2022 to reduce the existing backlog. Each inspection is carefully considered on a case-by-case basis where there is an imminent public health need. Factors such as risk to the FDA investigator and site personnel are also considered when determining if a virtual audit is appropriate.

 

Onsite inspections could be the standard inspection with the investigators staying in the facility the entire time or it could be a hybrid approach where the investigators spend some time in the facility and other time doing remote FDA reviews and conducting video interviews.

 

2022 will bring a new wave of inspections to the medical device and pharmaceutical industry. So how can you prepare in advance? And what does good look like from a virtual inspection process? Below are some thoughts for your team to consider.

 

Ready to Conduct a Mock Virtual Audit? Contact Us Now →

 

How Does an FDA Inspection Work?

 

FDA registrations simply don’t end and some health authorities outside the US have already done remote FDA inspections (e.g. the EMA). However, while the FDA has not done a true remote inspection, they have done many hybrid inspections.

 

What does an FDA inspection mean?

 

With the FDA format, regulatory authority tools include video chat for activities inside the interview room. They also use technology like secure shared online folders for offsite document review. Companies prepared to manage FDA inspections under this new method stand the best chance of success after an inspection to have fewer FDA 483 observations in general.

 

The FDA could start with a records request and then come onsite, or vice versa. Remember, if it is a true inspection the FDA must provide the most senior ranking person at the site a Notice of Inspection, Form FDA 482, at the very start of the inspection. If the Form 482 isn’t issued, then it is likely a records request utilizing their Section 704(a)(4) authorities.

 

FDA inspection

 

FDA record requests should follow the process and guidance outlined in their internal Staff Manual Guide, SMG 9004.1 Policy and Procedures for Requesting Records In Advance of or In Lieu of a Drug Inspection. Think of the SMG as an internal procedure for the FDA. If you are curious you can find it at this link: Staff Manual Guide 9004.1 (fda.gov)

 

 

Bottom line, if the FDA’s request comes through a call or email then it is not an inspection. It is a records request and should follow the procedures in SMG 9004.1. If they show up onsite, present a Form 482, then it is an inspection. Then the inspection could stay all onsite or it could be a hybrid approach, as noted above.  

 

Planning for an FDA Inspection

 

With the current pandemic, FDA has been providing a little advanced notice of the inspection, usually a few days to a week. The notice is directed less at giving companies time to prepare and instead intended to ensure the required personnel, who may be working offsite, are available. But prior planning precludes poor performance, so prepare well beforehand to manage a hybrid virtual inspection.

 

Some recommendations for inspection prep and readiness are as follows:

 

  • Determine who in the company will host the FDA inspection. Whether it’s onsite or virtual or hybrid you’ll want to designate a host. This distinction lets you train someone for the role, which helps streamline the process and eliminates last-minute challenges
  • Who will be the scribe and how will they take notes and communicate with the site team?
  • Determine who will step in as the back-up host and scribe in case the primaries are out sick.
  • Think through how the FDA inspection will flow, from the time it starts, through the facility tour, document requests and employee interviews.
  • If a virtual walk-through is conducted do you have sufficient Wi-Fi capabilities across the entire facility to avoid glitches in the audit and video.
  • How will you do the video? Use a phone camera or a real video camera.
  • Make sure you have the equipment ready to go and have tested it throughout the site.
  • How do you plan to maintain appropriate social distancing? Some companies have set up conference rooms complete with plexiglass barriers, tape markers on the floor and separated seating. In other cases, some activities are conducted outdoors, weather permitting.

 

Some additional helpful tips based on our experience with other clients are:

 

  • Collecting documents: This one can take a little time and it’s suggested that you start with the basics that you know the investigator will request, for example, a general site presentation, a batch record, deviation list, complaint list, facility layout, CAPA list, compliance documents, change controls and other master files.
  • Scanning and saving: Scan these documents ahead of time and upload them to an online company drive that is easily accessed by the inspection team.
  • Getting the right equipment: Whether you plan to use a smartphone or Wi-Fi camera, make sure the user knows how to operate it correctly and it works in every nook and cranny of your facility.
  • Running simulated inspections: A walkthrough lets you test video and audio quality. You can also identify and address poor Wi-Fi connectivity.

 

Virtual and hybrid inspections are a new format, and there can be challenges on both sides. Make sure your plan has some flexibility. Also, keep an eye on the FDA’s website for any announcements on virtual inspections. If the FDA does decide to start conducting virtual inspections it is likely that they will also roll out internal processes and procedures to ensure a harmonized approach. These items could be a Staff Manual Guide or a new chapter in their Investigations Operations Manual (Investigations Operations Manual | FDA).

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

FDA inspectionRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

US FDA Consultants

Posted on by Brandon Miller

About Regulatory Compliance Associates

 

Regulatory Compliance Associates (RCA) provides US FDA consultants & consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

About RCA’s Pharmaceutical Consulting Services

 

Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading US FDA consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every step of the FDA consulting process. Our FDA 510k consultants will create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our FDA regulatory consultants span all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your FDA regulatory consulting services partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep by FDA consulting firms could mean significant and lasting consequences for client revenue and industry profitability. At Regulatory Compliance Associates, we offer the experience and FDA compliance consultants necessary to guide you in quality compliance.

 

  • Compliance Enforcement
  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality life science consultants with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support

 

Remediation Services 

 

Regulatory Compliance Associates® has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and compliance enforcement. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, Regulatory Compliance Associates can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA’s Medical Device Consulting Services

 

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA®‘s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 life science consultants — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates, we offer a wide variety of services for medical device security to help ensure that your product is protected from cyber-attacks.

 

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA 510k consultant experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

 

Our network of over 500 FDA, Health Canada & MHRA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

Regulatory Compliance Associates Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our life science consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry Experts are fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Services

 

Regulatory Compliance Associates is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve remediation services challenges. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates life science consultants can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

 

Our 500 industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Pharmaceutical Manufacturing

Posted on by Brandon Miller

Whether building a new facility (greenfield) or upgrading a pharmaceutical manufacturing site (brownfield), it is important to understand the regulations governing facilities and inspection readiness. The Code of Federal Regulations Part 211 governs the United States, Eudralex Volume 4 governs the European Union, and the Ministry of Health, Labour, and Welfare govern Japan.

 

GMP Pharmaceutical

 

Knowing the pharmaceutical manufacturing requirements for these regions is important information needed to assist your decision on whether it is more feasible and economical to build a new facility or upgrade an existing facility. Whatever decision you decide to make, Regulatory Compliance Associates Inc. can help you achieve a successful outcome.

 

Need help upgrading or building a new facility? Talk to our Experts →

 

The pharmaceutical industry has been trying to become more efficient from both manufacturing and regulatory perspectives. The challenge is to improve processes, quality systems, and manufacturing capabilities while operating efficiently and in a manner. Core to the belief of quality culture is developing pharmaceutical active ingredients that ensure safe, effective, and cost-efficient medicines to patients.

 

Pharma Manufacturing

 

Many pharma manufacturing and quality system updates can be easily and readily implemented with little or no impact on regulatory filings. When a change impacts regulatory filings, it has the potential to disrupt the supply chain if it is not handled appropriately and as efficiently as possible. FDA seems to recognize these situations and has been working to help lessen the regulatory filing burden to companies while not affecting the quality of the products.

 

Regulatory Filing

pharmaceutical manufacturing

 

If you are a contract manufacturer the first step in the process of upgrading your facility is to get the agreement, or at least, an acknowledgment from your clients that they are aware that you intend to upgrade the facility and that it may affect their regulatory filing.

 

Quality Agreement

 

Both your pharmaceutical factory and your client(s) may have responsibilities outlined in the quality agreement regarding maintaining and upgrading the facility and the decision to upgrade an existing Pharma facility should be made with the knowledge and input of your client(s).

 

Pharmaceutical Production

 

Using a comparability protocol is a great way to communicate your intended upgrades to your client. Employing the use of a comparability protocol you are, in essence, making sure your client understands the pharmaceutical production change you will be implementing and the data you will be collecting and reviewing to assess that the upgrade was successful and did not affect product quality. The comparability protocol is a nice compromise when you are dealing with multiple clients who have different regulatory filing strategies.

 

FDA Regulation

 

The best way to upgrade a facility in a timely manner is to make sure you have a robust quality agreement in place that gives you the responsibility for maintaining your facility, become familiar with FDA regulations and use them to justify your recommendation, and finally, use a comparability protocol for medicine production like-to-like equivalency. These steps should help you implement a facility upgrade promptly while reducing your downtime to improve.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Process Analytical Technology

Posted on by Brandon Miller

Leveraging Process Analytical Technology for CMC

 

Introduction

 

In the evolving field of pharmaceutical development, the implementation of Process Analytical Technology (PAT) for manufacturing is an essential competitive advantage. PAT offers widely accepted methods to safeguard quality assurance and the general safety of pharmaceutical products. The goal of this article is to provide a summary of PAT, best practices of principles and adoption of PAT, and how to leverage increased process knowledge in your regulatory submission.

 

Understanding Process Analytical Technology (PAT)

 

Efficient pharmaceutical manufacturing is a significant facet of the global healthcare system. The well-being of patients is contingent on the accessibility of safe and effective treatments. The U.S. Food and Drug Administration (FDA) framework for process analytical technology was originally established based on insights to facilitate quality improvement. It includes risk-based regulatory outcomes that have been validated by both life science manufacturers and FDA regulators.

 

The Agency framework is based on two primary drivers:

 

  • Scientific principles and tools that support the development of innovation
  • Regulatory strategies that accommodate innovation during the submission process

 

Principles of Process Analytical Technology

 

CMC (Chemistry, Manufacturing, and Controls) is one of the most influential facets of drug product development. Traditional drug development in pharmaceutical manufacturing is completed using batch processing and production sample lab testing to evaluate quality. This approach has been effective in delivering quality pharmaceuticals to patients in need.

 

However, modern technologies now offer life science employees the opportunity for improving pharmaceutical development. Specifically, PAT principles and technologies focus on increasing quality assurance during the product development process. This often involves the use of unique quality controls from different types of technologies.

 

Process Analytical Technology and CMC

 

The implementation of process analytical technology encourages drug manufacturers to create a team-based regulatory approach to chemistry, manufacturing and controls. Further, the review of current good manufacturing practices (cGMP) is also essential to the success of process analytical technology.

 

Finally, in-depth CMC training is important to achieve certification in process analytical technology. This is important considering the regulatory inspection review by Agency auditors for each new drug in development. The ability to demonstrate regulatory compliance is a foundational training strategy that supports the use of process analytical technology in manufacturing.

 

Implementing Process Analytical Technology

 

In the past, many manufacturing procedures have been considered static due to regulatory constraints. Proposed process changes are often considered for feedback by FDA early in the regulatory submission process. However, this can also lead to ambiguity of what types of technology will be authorized or declined by the Agency going forward. Life science manufacturers often stick with what is approved to stay in compliance and not raise red flags with FDA.

 

Recognizing the need to reduce this ambiguity for embracing innovation, FDA launched an initiative called Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach. The goal of this program is to ensure process analytical technology principles are known by life science companies and include:

 

  • Modern concepts of risk management
  • Quality system approaches are incorporated into pharmaceutical manufacturing while maintaining product quality
  • Life science manufacturers are encouraged to use modern innovations in pharmaceutical manufacturing technology
  • FDA’s submission review and inspection programs operate in a coordinated manner
  • Regulations and manufacturing standards are applied consistently by FDA and the manufacturer

 

Benefits of Implementing Process Analytical Technology

 

FDA considers process analytical technology to be:

 

“a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.”

 

The primary benefit of implementing process analytical technology is to enhance understanding and control of the manufacturing process. Consequently, the tools and principles of process analytical technology should increase the level of manufacturing process understanding in general.

 

Manufacturing Process

 

Further, meeting the regulatory requirement of validating the manufacturing process can only benefit from this understanding of what quality looks like. Five core ingredients of process analytical technology strategy that should help users boost their understanding include:

 

  • Enhanced process understanding and knowledge
  • Improved process control and efficiency
  • Reduction in production costs and waste
  • Faster and more efficient product development
  • Enhanced regulatory compliance

 

Adoption of Process Analytical Technology

 

Equally important, for the manufacturing team’s adoption of new technologies to be successful, employees must recognize the importance of quality assurance and patient safety. Moreover, proposing innovative approaches to pharmaceutical development should not lead to a regulatory stalemate between FDA and the life science manufacturer.

 

FDA encourages manufacturers to use the process analytical technology framework in clinical documentation, so a stalemate doesn’t occur during the regulatory process. This can include clinical evidence that helps demonstrate:

 

  • Process understanding and control strategy
  • Real-time process monitoring
  • Multivariate data analysis (MVDA)
  • Process control and optimization
  • Continuous manufacturing and quality by design (QbD)

 

Process Analytical Technology Manufacturing Examples

 

FDA has provided process analytical technology examples of the tools available that facilitate manufacturing process understanding. These converge at the intersection of scientific, risk-managed pharmaceutical development, manufacturing, and quality assurance.  

 

When used within an effective manufacturing system, process analytical technology can provide effective and efficient means for facilitating process understanding. Further, continuous improvement, and development of risk-mitigation strategies. In the PAT framework, PAT manufacturing examples can be categorized according to the following:  

 

  • Multivariate tools for design, data acquisition, and analysis
  • Process analyzers
  • Process control tools
  • Continuous improvement and knowledge management tools

 

Process Analytical Technology and Quality Assurance

 

Process analytical technology and quality assurance go hand in hand when it comes to manufacturing innovation. The above performance metrics for measuring quality focus on designing, analyzing, and controlling manufacturing through timely measurements of raw and in-process materials and processes.

 

For the same reason, process analytical technology commonly includes tools that can improve chemical, physical, microbiological, mathematical, and risk analysis. Simultaneously, these quality assurance tools that aid process understanding can also support meeting existing regulatory submission requirements to validate the manufacturing process.

 

Process Analytical Technology and Regulatory Approval

 

Achieving regulatory submission approval for a new product is rarely an easy process. The clinical evidence needed to support efficacy must include documentation of quality assurance delivered by the manufacturer.

 

Innovation in development, manufacturing and quality assurance that leverages process analytical technology should help answer these common regulatory questions from FDA experts:

 

  • What are the mechanisms of degradation, drug release, and absorption?
  • What are the effects of product components on quality?
  • What sources of variability are critical?
  • How does the process manage variability?

 

Regulatory Submission

 

Regulatory considerations that can help document quality assurance improvements from process analytical technology often are found in:

 

  • Reducing production cycle times by using on-, in-, and/or at-line measurements and controls
  • Preventing rejects, scrap, and re-processing
  • Real time release
  • Increasing automation to improve operator safety and reduce human errors
  • Improving energy and material use and increasing capacity
  • Facilitating continuous processing to improve efficiency and manage variability

 

Regulatory Documentation

 

Quality assurance improvements are centered around the manufacturing process and system processes involved. FDA considers a process to be well understood if regulatory documentation shows:

 

  • Why sources of variability can be identified and explained
  • When production variability can be managed by owners of the process
  • How quality attributes can be accurately and reliably predicted

This type of regulatory documentation provides insights for FDA regulators into materials used, an understanding of process parameters, changes in manufacturing, and environmental conditions.

 

The ability to predict these three items can show a high degree of process understanding. The goal is for your regulatory application to demonstrate your team and company understand how to reproduce process capability data and maintain a consistent state of control.

 

Conclusion

 

Process analytical technology is used to improve the scientific basis for regulatory specifications and promoting continuous improvement. The ability to enhance manufacturing while retaining or improving product quality is essential to helping patients and population health in general. Life science manufacturers should document technology improvements to FDA and demonstrate the ability to quickly resolve production-related technical issues.  

 

About the Author

 

Erika PorcelliAs Vice President of Regulatory Services for Regulatory Compliance Associates® (RCA), Erika Porcelli touches all aspects of the customer experience. RCA provides consulting services to life science organizations for the resolution of compliance and regulatory challenges. RCA is a global business unit of Sotera Health, a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

 

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