Services: Compliance Assurance-Pharma

For Pharmaceutical Industry

FDA Inspections: Hope is Not a Strategy

Subject matter experts from Regulatory Compliance Associates® Inc. discuss how too many organizations scramble when an FDA inspection occurs because they fail to be adequately prepared. True inspection preparedness, however, supplements internal audits with a practiced inspection process and focused behavioral training.

 

 

Internal Audit

 

While internal audits are a key component of inspection preparedness, they tend to be informal, less intense, and more focused on auditing than inspecting. True inspection preparedness supplements internal audits with a practiced inspection process and focused behavioral training for key personnel.

 

Before a FDA inspection occurs, organizations should have an inspection process in place and conduct mock inspections. Like any process, inspection readiness needs a plan that is executed, assessed, and continuously improved upon. 

 

Roles & Responsibilities 

 

The Inspection Room (Front Room) 
While inspectors often walk the facility, the inspection room provides a meeting space to review documentation and answer questions from the inspectors. In this “front room,” system owners or subject matter experts (SMEs) review and present materials to the FDA inspector. 

 

The Control Room (Back Room) 
The control room provides the documentation, interviewees, and preparation that is needed to support the inspection process. This “back room” team processes requests for information, retrieves documents from electronic systems, and also triages documents as needed. The control room is staffed with quality and technical personnel who log requests for information and alert department heads within the organization. 

Control room personnel should always:

  • Conduct a minimum of two reviews of every document prior to sending it to the inspection room:
  • Quality Review:
    • Make sure it points to valid SOPs and Work Instructions, etc.
  • Technical Review:
    • Make sure the SMEs have reviewed and are prepared to speak to the process with the inspector
  • Have back-up printers, toner, copiers and paper on hand

Some organizations appoint runners to take the data back and forth between the control room and inspection room. There are technology solutions to operationalize the inspection process as well. 

 

Behavioral Training

 

In the past, employees were often trained to give curt answers to FDA inspectors to avoid inadvertent revelations to the agency. This approach created fear and mistrust among employees, and set up adversarial relationships with FDA staff. In order to create the most beneficial inspection process environment, however, both the agency and the company need to form a partnership. Key behavioral tips for success include:

 

  • Empower the inspection and control room teams.
  • Bring SMEs into the control room to help gather data, review documents, and consult on the answer before they are summoned to the inspection room.
  • Help SMEs understand their role in the bigger picture of the inspection. Prep them on related questions that have already been asked.
  • Don’t allow an SME to bring in notes or an uncontrolled document.
  • Use the control room to debrief SMEs after meetings with the inspector.
  • Anticipate and prepare. The language used in inspector requests can provide insights. Anticipate next questions, proactively pull documents, and understand related metrics. For example, if the inspector asks about CAPA, review related documents such as open CAPAs, high-risk CAPAs, the average length of time for CAPAs, and the longest time for open CAPAs. Be prepared to answer the inspector’s next questions.

Practicing the inspection process, however, can be one of the best ways to help employees learn appropriate behaviors and response techniques. Train employees to:

 

  • Focus on the question asked; restate the question when unsure of what’s being asked.
  • Readily admit to not knowing an answer, but provide a date and time when the answer will be provided.
  • Create an environment that reinforces the positive but recognizes weaknesses, such as “we understand this is an area for improvement,” rather than “this has been a problem for a long time.”
  • Recognize the need for training across the organization on inspection readiness. Consider off-site locations as well. The FDA inspection process starts when the FDA inspector pulls up into the parking lot and interfaces with reception and security personnel. Don’t limit inspection training to just inspection and SME personnel.

 

Mock Inspections

 

Many companies conduct internal audits as part of their inspection readiness strategies. Mock inspections, however, take the next step and allow companies to actually practice the inspection room, the control room, and inspector interaction. 

 

During mock inspections, organizations set up inspection rooms and control rooms to help teams learn how to readily access documentation that would potentially be requested during an inspection. Additionally, these practice sessions give employees an opportunity to demonstrate proper behavior and interviewing techniques when working with the regulatory agency. 

 

A mock inspection can also be used to probe further on issues uncovered during internal audits. The mock Inspection team should bring in SMEs and other personnel as needed for this activity. This approach helps the organization fully understand areas needing improvement, and gives them a platform to take corrective action before the agency actually arrives.

 

Being properly prepared for inspection ensures that the inspection process will run smoother, decreases the likelihood of observations, and helps groom the organization and individuals for higher levels of future performance. 

 

Published by:

 

 

 

Medical Device and Diagnostic Industry.

 

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. 

 

Audits

Using a risk-based compliance audit approach, Regulatory Compliance Associates (RCA) will help your company identify and correct deficiencies and choose solutions to determine readiness for inspection. We will work with your personnel to help get them ready for inspections. Every Regulatory Compliance Associates certified auditor follows a precise audit risk model. When it comes to internal control and audit planning, you’ll find that our audit services team of Experts is second to none.

 

Type of Audits

 

  • Business audit
  • Company audit
  • Compliance audit
  • External audit
  • Internal audit
  • Integrated audit
  • ISO audit
  • FDA audit
  • Forensic audit
  • Medical audit
  • Operational audit
  • Performance audit
  • Quality audit
  • Single audit
  • System audit
  • Virtual audit

 

RCA’s clients work with a certified auditor who can provide you with audit risk findings and an audit risk assessment after the project. Each certified internal auditor understands how to strategize with your audit committees and present evidence found through substantive procedures. Additionally, ASQ-CQA or RABQSA-certified auditors are available for the following:

 

  • Document Control Systems Implementation and Remediation
  • Supplier Audits
  • Current Good Manufacturing Practice (cGMP) Compliance Audits:
    • Manufacturing, Pilot Plant, Laboratory Facilities
  • Current Good Laboratory Practices (cGLP) Compliance Audits
  • Good Clinical Practices (GCP)
  • Regulatory Gap Analyses
  • Risk Assessment
  • Pre-Approval Audits
  • 21 CFR Part 11 Gap Analysis
  • Software Analysis
  • Combination Products
  • 503A and 503B Compounding
  • Development of Inspection Checklists
  • Quality System Compliance Audit
  • Internal Audits
  • Contract Manufacturer Audits
  • Supplier Audits
  • Virtual Audits

 

The RCA Advantage

 

Compliance gaps can sometimes blindside even the most prepared medical device companies during agency inspections. Teaming with Regulatory Compliance Associates® ensures you’ll be as prepared as possible to face scrutiny from regulatory bodies.

 

As an industry-leading risk assessment consultant, we offer a host of benefits you won’t find anywhere else:

 

  • Our staff are seasoned audit experts — many have decades of experience working with the FDA and preparing for FDA inspections. We offer these unique insights and in-depth knowledge to your business so that you know exactly how to plan for your inspection.
  • We not only have the knowledge and means to perform thorough audits, but we also have the processes in place to help you make sense of findings and manage the corrective action process.
  • Not only does our team monitor the little problems that regulatory agencies are likely to uncover, but we also take care of the big picture as we ensure the compliance of your overarching quality system.

 

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

 

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. 

 

Compliance and Quality Assurance Services

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 or developing a response to an FDA finding, Regulatory Compliance Associates (RCA®) team of compliance assurance consultants can help.

Every regulatory body takes its responsibility seriously to ensure the products consumers rely on meet a rigorous set of legal standards for quality, safety and effectiveness. RCA’s business consultant Experts are internationally known in the regulatory compliance industry for Safeguarding Global Health® with every new product approved.

 

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. Our pharmaceutical consulting Experts will create a customized approach depending on your product and 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. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, 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. Finally, our regulatory compliance services team excels in transferring continuous improvement 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, Regulatory Compliance Associates 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. 

Regulatory Compliance

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.

 

Q: I just attended a meeting where someone talked about the concept of real compliance. Can you explain what they were referring to?

 

A: This is a great question because I believe there is a difference between regulatory compliance and real compliance. Naturally, let’s start with what we mean by regulatory compliance.

 

cGMP

 

The current good manufacturing practice (CGMP) regulations for drugs contain minimum requirements for the methods, facilities, and controls. Subsequently, cGMP is also critically important in the manufacturing, processing, labeling, and packaging of drug products.

 

Regulatory Compliance

 

In the United States, some of the laws are delineated in section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act, which states:

 

“A drug shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packaging, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this [Act] as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess” .

 

 

regulatory compliance

US Title 21 Code of Federal Regulations (CFR) Part 211 establishes the regulations based on the law. For instance, the regulations contained in 21 CFR Part 211 do not tell you how to specifically meet these regulatory requirements.

 

FDA Inspection

 

Instead, the law tells you what is expected of your quality management system (QMS) in order to achieve compliance to the regulations. The goal of regulatory compliance is to both satisfy the regulations and achieve a satisfactory outcome during an FDA inspection.

 

Compliance Regulations

 

Real compliance is how a company interprets compliance regulations and regulatory expectations, and apply them to their specific operations. Real compliance is rooted in a commitment to quality at all levels of an organization.

 

A real compliance approach takes a high-level view of quality and allows the organization to put in controls that help prevent deviations from occurring. It also provides a better understanding of the impact of regulatory and compliance deviations when they occur during manufacturing.

 

Regulatory Risk

 

Organizations that adopt a quality-based philosophy (real compliance) minimize the regulatory risk when deviations of a serious nature occur. Real compliance is the practical application of a quality management system and how it is integrated into modern manufacturing.

 

Manufacturing Processes

 

The quality commitment of real compliance lies within manufacturing processes. The goal is to achieve a sustainable state of control based on certified regulatory compliance. This includes at the manufacturing facility based on scientific principles, best practices, and continuous improvement efforts. The best way to explain the difference between regulatory compliance and real compliance is to perform a thorough regulatory risk management exercise.

 

21 CFR Part 11

 

The regulations clearly require companies to have written procedures that are in the form of standard operating procedures (SOPs). The common language used in 21 CFR Part 211 to indicate SOPs are required can be exemplified by 21 CFR 211.22

 

“Responsibilities of quality control unit”, which states “(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed” (2).

 

This type of wording can be found is sections of 21 CFR 211 governing personnel qualifications, building and facilities, equipment, production and process control, labeling issuance, warehousing procedures, etc. The regulatory requirement is met by having SOPs, but real compliance is met having SOPs that reflect your operations during a regulatory audit.

 

Standard Operating Procedure (SOP)

 

For example, data compliance regulations change from insourcing and outsourcing. If you outsource product testing you would not need an SOP on how to investigate out of specification (OOS) results because you are not performing that activity. Instead, you might replace it with an SOP describing how you work with your contract test laboratory when they are investigating an OOS result associated with your product.

 

Complaint Management

 

Another example between regulatory compliance and real compliance is just having a complaint department vs. handling customer complaints correctly. Complaint handling involves employees who understand and trained to manage customer complaints.

 

Design for Manufacturing

 

Further, training should consider design for manufacturing and how employees are empowered to resolve each customer complaint. Another difference between regulatory compliance and real compliance is having an organization chart that separates the quality & operations team. As an illustration, have your organization chart demonstrate where quality has the responsibility and authority to operate independently.

 

Compliance Example

 

Here’s a more practical example of regulatory compliance vs. real compliance. US 21 CFR 211.25(a) requires:

 

“Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience or any combination thereof, to enable that person to perform the assigned functions”.

 

A regulatory compliance approach would be to offer every employee annual GMP training and document their attendance. A real compliance approach would be to provide effective training to the employees by assessing their comprehension of the material and offering follow-up training as necessary.

 

Compliance Investigation

 

Another practical example of regulatory compliance vs. real compliance is examining how a company approaches investigations. A strictly regulatory compliance approach to an investigation results in a firm not determining the true root cause of an issue. Equally important, compliance investigation processes focus on the quality of the investigation instead of completing the investigation in a specific time frame.

 

Root Cause

 

Real compliance organizations focus on determining the true root cause(s) and using that information across their manufacturing facility to drive continuous improvements and prevent recurrence of the deviation that prompted the investigation. Taking a regulatory compliance only approach to operations may be less expensive in the short term. 

 

Article details

 

 

 

 

 

BioPharm International
Volume 35, Number 10
Pages 54, 52

 

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. 

 

Internal Audit: Be Ready For FDA Inspections

Life science companies understand the FDA inspection process is a cornerstone towards ensuring safety and efficacy in products. When companies conduct an internal audit and are prepared for inspections, it is easier for the FDA personnel to do their jobs of assessing compliance. Being prepared for inspections is not about cutting corners or feigning compliance, rather it is about everyone doing their part to ensure safety and efficacy. Patient safety is the top priority.

 

True inspection preparedness supplements internal audits with a practiced inspection process and behavioral training for key personnel.

 

Inspection Preparedness

Despite this knowledge, many organizations get bogged down in the day-to-day or get consumed by special projects. This results in inspection preparedness taking a back seat. For many medical device, biotech and pharmaceutical companies, inspection readiness becomes simply the internal audit program.

While internal audits are a key component of inspection preparedness, they tend to be informal, less intense and focused more on auditing than inspecting. True ISO audit inspection preparedness includes a practiced inspection process and audit training for employees.

Inspection Process

Before an FDA inspection occurs, organizations should have an inspection process and practice through mock inspections. Like any process, inspection readiness needs a plan that is executed, assessed and continuously improved upon.

Ideally, the inspection process will encompass the activities of the Inspection Support Team. Process managers will assign employees to the Control Room. System Owners will collaborate on requests with the functional subject matter experts (SMEs).

Inspection Support Team

The Inspection Support Team is the primary interface with the FDA inspector. Team roles for audit control include the Inspection Coordinator, System Owners (or SMEs), the Escort and the Scribe. See below for an overview of the roles and responsibilities during an FDA inspection.

 

FDA Inspections

 

Inspection Room (Front Room)

The Inspection Coordinator manages the system of internal control and overall process in the Inspection Room. While inspectors often walk the facility, the Inspection Room provides a focal point for the FDA inspection. It is where questions are asked and answers are presented to inspectors. Moreover, this room is sometimes referred to as the Front Room where access to documentation should be readily available.

The Escort is the primary point of contact for the FDA inspector. This role manages the conversation with the Agency and completes audit data requests. These Front Room requests are given to a runner who then delivers to team members inside the Control Room. Further, the Control Room is commonly referred to as the Back Room of an inspection.

Control Room (Back Room)

After receiving the internal audit process request, the Control Room responds by either accessing documentation or setting up interviews with appropriate personnel. Data moves electronically or physically back and forth between the Control Room and Inspection Room. Additionally, video can also help augment data sharing among both teams. 

The System Owners (e.g. SME’s) review and present materials to the FDA inspector. This role also provides continuity and context for answers. After SME’s are dismissed from the Inspection Room, they will return to the Control Room for debriefing and note taking similar to GMP audits.

Conversation Scribe

The Scribe is present for internal audit reporting and general conversation notes that are ongoing in the Inspection Room. These notes aid the team during and after the inspection. They are useful in developing responses needed in the moment or if future FDA observations arise.

Instant messaging, which has become popular in ISO 9001 audit formats due to the pandemic, is an asset between the Front and Back Rooms. Using technology to communicate instantly increases the collaboration about the critical issues being discussed.

For example, imagine if documents were not being delivered in a timely manner to the inspector and she/he is becoming anxious. It is helpful for the Inspection Room to stay connected with the Control Room about each audit need and the expected delivery time-frame. 

Control Room Coordinator

The Control Room provides the documentation, interviewees and preparation that is needed to support the inspection process. This Back Room team, led by the Control Room Coordinator, processes requests for information, retrieves documents from electronic systems and also triages documents as needed.

The control room is staffed with quality and technical personnel who log requests for information and alert department heads within the organization. The control room helps to anticipate and prepare for the next potential questions from the inspectors.

Document Requests

The control room staff accesses and prepares the requested documentation for the SMEs. The SME process involves reviewing the retrieved documentation, preparing for a discussion with the inspector and then presenting in the Inspection Room.

SMEs are escorted to and from the Inspection Room for any last minute questions and to ensure debriefing occurs after interviews are completed.

Case Study

The Inspection and Control Room can scale up or down with the nature of the inspection. For example, one organization had FDA inspectors and other auditing bodies on-site for six months. Three Control Rooms were set up which had nearly 100 employees supporting the process and driving efficiencies in providing requested documentation.

Behavioral Training

In years past, organizations were known to train ISO internal audit employees to also give curt answers to FDA inspectors in hopes that nothing more would be revealed externally to the agency. This approach created fear and mistrust among employees and set up adversarial relationships with the FDA staff.

Practicing the inspection process can be one of the best ways to help employees learn appropriate behaviors and in order to create the most beneficial inspection process environment, both the agency and the company need to form a partnership. Both the agency and industry want to provide safe and efficacious products, and both understand the role inspections play.

Mock Inspection

Many companies conduct a risk based audit as part of their inspection readiness. Mock inspections take the next step and allow companies to practice the Inspection Room, the Control Room and the right behaviors in working with inspectors to help them access information needed.

A mock inspection can be used to probe further on issues uncovered during internal audits. The mock Inspection Team should bring in SMEs and other personnel as needed for this activity. This helps the organization fully understand areas needing improvement and gives them a platform to take corrective action before the Agency actually arrives.

 

Too many organizations scramble when an FDA inspection occurs because they fail to be prepared. Since organizations don’t perform optimally on the fly, it’s important to prepare and practice the inspection strategy in advance, not simply rely on internal audits to ready the organization.

 

Summary

Best practice organizations understand inspection preparedness is vital in working with the agency to ensure safe and efficacious products. Inspection readiness involves both internal audits and mock inspections.

During these mock inspections, organizations set up Inspection Rooms and Control Rooms to help teams learn how to readily access documentation which would be requested during an inspection.

Additionally, these sessions give employees an opportunity to demonstrate proper behavior and interviewing techniques when working with the agency. Being prepared ensures that the inspection process will run smoother, decreases the likelihood of observations and helps groom the organization and individuals for higher levels of future performance.

 

Hope is not a strategy.

 

FDA Inspections

 

 

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. You may also email us at [email protected].

 

Conducting an Internal Audit

The audit function of a pharmaceutical company is one cornerstone of an effective and efficient quality management system. There are several types of audits that comprise a robust auditing program including supplier audits, internal audits, and regulatory audits. Each of these specific audits requires preparation to make sure the audit is productive and accomplishes its intended purpose, which, in the manufacturing world, is to ensure facilities are manufacturing fit-for-use products in full adherence (hopefully more) to current good manufacturing practice (CGMP) requirements.

 

Supplier audits are performed to confirm that the suppliers of raw materials, packaging, and labeling components, etc., are able to provide a continuous, uninterrupted supply of materials that are compliant with CGMPs. Regulatory authorities perform inspections to determine if the manufacturing company is providing materials that comply to CGMPs. Internal audits are performed by the company as a self-assessment for the purpose of identifying areas/issues that might affect their compliance status.

 

Pre-pandemic, preparing for a supplier or regulatory audit typically consisted of the regulatory inspector or the auditor for supplier/internal audits providing the facility being audited with an agenda listing the areas to be toured (e.g., incoming raw material area, quality control [QC] chemistry and microbiology laboratories, manufacturing, etc.) and a list of documents to review (e.g., quality manual, list of standard operating procedures, open deviations, and corrective and preventive actions [CAPAs]) and any additional supporting evidence the auditor chooses to review. This information helps auditing authorities assess and decide the compliance status of the facility.

 

Performing external audits during a pandemic

The documentation that would have been reviewed on-site pre-pandemic is the same documentation that is needed for review during and post the COVID-19 pandemic. The documentation and supporting evidence review conducted pre-pandemic would most likely have occurred at the facility. However, audits conducted during the pandemic require the documents and supporting evidence to be shared electronically to the auditor using secure electronic systems. This electronic exchange helps make time more efficient for both the auditor and the facility being audited. The documentation can be reviewed by the auditor, and questions can be communicated to the audit manager via email or conference/video calls. While this may not be ideal, because it eliminates the in-person interaction, it is still an effective way to conduct an audit when there are conditions prohibiting face-to-face interaction.

 

Touring the facility is challenging when the audit is conducted during a pandemic, but challenges can be overcome with some flexibility and ingenuity. Live video feed could be streamed to the auditor while the company’s audit manager and/or subject matter experts are available to answer questions that might arise during the live feed. Additionally, operations could be recorded, and that recording could be provided to the auditor, again with the understanding that the audit manager would be available to answer any questions posed by the auditor upon the review of the video. While the recorded version of the tour is probably not the most ideal, because the auditor needs to see things in as real time as possible, it does allow for the auditor to pause and go back to review a specific operation in more detail if warranted.

 

Internal audits during a pandemic

Preparing for an internal audit requires the same discipline as preparing for supplier and regulatory audits. During the COVID-19 pandemic, many companies reduced the number of employees allowed at the site, and many of the quality personnel that conducted audits were allowed to work remotely. Internal audits are part of management responsibilities (1–3) and must continue to be performed, even during a pandemic.

 

Conducting an internal audit is different from the other audit types, whether it is pre-, during, or post-pandemic. If designed and implemented appropriately, the value of the internal audit is that it allows the company to find vulnerabilities in their systems and remediate them before they are discovered by an external auditor. Internal audits can provide valuable information that can be used to prevent issues before they become compliance concerns. If these issues can’t be completely remediated before an external audit, a plan to correct them can be established and action taken to mitigate them. Having corrective actions in place before others identify the issue may lessen the impact of the observation and instill confidence that your quality system is under control and there is a process in place for continuous improvement. In addition, the internal audit can be used for training staff and communicating valuable information to the organization.

 

The ideal tone for an internal audit should be a collaborative team-oriented activity that is instructive, informative, open, honest, and inclusive. There are several factors that help contribute to establishing this tone, even during a pandemic. One way to set the proper tone is to publish the audit schedule/agenda in advance and make sure the functional areas personnel are informed of the schedule. During a pandemic, the agenda takes on another level of importance because it ensures that the site can have the proper documents ready to go and upload them either before or during the audit. Prior planning precludes poor performance in this area.

 

The auditors should work with the functional area and talk with as many employees as possible to identify the issues of concern. Individuals who are responsible for performing the day-to-day activities often have the best insight as to what is working and what needs to be improved. Excluding them from participating in the audit process might result in overlooking a serious issue that could come up during a regulatory inspection or inadvertently lead the auditor to think the site is hiding something. To be able to get the most valuable information about the potential compliance issues facing the organization, internal audits should not be judgmental or antagonistic, or have a ‘check the box’ mentality in execution.

 

Auditors should be direct and avoid asking questions designed to intentionally stump people. Another important behavior is the ability of the auditor to listen to the answers personnel give and refrain from judging. The exact same behavior defined for the auditor should also be the exact same behavior displayed by the auditees. Auditees should be direct and avoid deflecting or obfuscating answers and take the time to explain why they do things the way they do them. They should be proactive and point out things of concern and seek advice on how to remediate them. Both parties need to remember they are not enemies, rather they are the partners in improving their organization together.

 

Conclusion

Conducting audits during the pandemic has presented a multitude of challenges. The pandemic has allowed the industry to creatively utilize technology-based applications to communicate and perform an effective audit. The documentation and supporting evidence review can be conducted remotely, and confidentiality can be maintained. After reviewing the documentation and supporting evidence, the auditor can request interviews with various personnel, which can then be scheduled via video conferencing.

 

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing. The post-pandemic sweet spot will likely be balancing remote and in-person audits.

 

 

BioPharm International

Vol. 34, No. 2

Pages: 44-45

 

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.