Services: Compliance Assurance-Pharma

For Pharmaceutical Industry

FDA Warning Letter

Background

A global health care company received an FDA Warning Letter for quality issues with its manufacturing facility. As the organization began working through the issues identified in the Warning Letter, it became clear, even with good quality systems, improved operational execution was needed to sustain successful results.

Operations Improvement (OI)

The operational improvements were focused in areas such as shop floor discipline / execution, facility housekeeping and maintenance, managerial focus on all levels and, most of all, assessing and attacking specific operational shortfalls within all the operational groups.

Solution

The manufacturing facility engaged Regulatory Compliance Associates® life science consultants to develop and implement a plan for data quality improvements to support the evolving quality management system.

Quality Management System (QMS)

This assessment and subsequent improvements involved needed support from the somewhat skeptical quality management system (QMS) group. RCA and the local operations management team worked jointly to assess the plant and identify gap areas needing improvement to support the quality initiatives.

 

RCA helped the organization recognize data quality gaps, develop action plans, and create tracking mechanisms to monitor operational progress of the Quality initiatives. RCA raised the bar on operational discipline and feedback.

Data Integrity (DI)

RCA assisted the facility to develop and implement a tracking system to monitor operational tasks, ongoing process improvements and ways to enforce accountability of key personnel. This tracking included key performance metrics for the following areas: training compliance, floor audit performance, batch record error improvement, document timeliness and line clearance performance.

Operational Excellence (OE)

Recognizing that the operations management team was inexperienced, RCA engaged and mentored the key operations floor managers as they began implementing improvements and tracking progress. Besides crafting and implementing the operations improvement plan, RCA assisted the company to instill a culture of operational excellence and individual accountability with an inexperienced team. RCA helped the organization recognize gaps, develop action plans and create a tracking mechanism to monitor operational progress.

Quality Assured

Not only did these actions clearly improve quality assurance (QA) and compliance, but they provided financial returns such as a deviation and inspection cost reductions as well as increased available line time which more than covered the cost of RCA’s third party support.

Quality Circle

Most importantly, the quality circle team learned the importance of communication across all departments and at all levels to achieve success. Ultimately, the facility’s commitment will contribute to an environment of sustainability long after the RCA consultants have left.

 

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. 

 

 

Warning Letter Remediation

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates® Executive VP of Pharmaceuticals, Steven Lynn, go over how RCA helped an international company perform a gap analysis based on multiple FDA investigations.

Listen in as we break down the client’s Warning Letter Remediation challenges, RCA’s approach to remediation, the ongoing work still taking place, and some advice on FDA Investigation Readiness.

 

About RCA Warning Letter Services

To protect public safety and maintain a high standard of quality in the pharmaceutical industry, the U.S. Food and Drug Administration (FDA) conducts investigations into companies that manufacture and package drugs. Both small start-ups and large pharmaceutical companies may be the subjects of FDA investigations. If the inspector observes conditions that seem to violate FDA regulations, they may issue a pharmaceutical warning letter. Depending on your company’s regulatory response to the letter, the FDA may close out the investigation or take FDA 483 legal action if deemed necessary.

 

Though receiving an FDA warning letter is not the end of the world, your company must understand the letter and respond appropriately. Conducting an FDA inspection may be necessary for you to achieve compliance, which can pose challenges if you aren’t sure what is expected of you.

 

What Happens After You Receive a 483 Inspection Observation or a Pharmaceutical Warning Letter

The FDA issues several types of letters to pharmaceutical companies. Depending on the situation, you may receive a Form 483, a warning letter or a consent decree. An FDA 483, which details a number of specific concerns, is issued after an investigation if an inspector sees conditions or practices they believe may violate the Food Drug and Cosmetic Act or other regulations. An FDA warning letter is issued to a company that has significantly violated FDA regulations and lays out a timeframe for corrections.

 

Whether you receive an FDA 483 or a warning letter, you are expected to develop a regulatory response to the FDA in writing. Included in your strategy will be an FDA Audit that addresses compliance issues through remediation as quickly and thoroughly as possible. Taking comprehensive action is essential to getting your company back on track. A well written FDA EIR is essential to proving concise and clear documentation for your activity. 

 

Resolving Compliance Issues at Your Company

 

If the FDA issues you the unique types of FDA 483 warning letters, Regulatory Compliance Associates® Inc. can assist in developing a response that will be accepted by the Agency and be realistic for your organization to execute. We can prepare a strategy and implementation program to help remediate the observations, as well as develop a comprehensive proof book. 

Our list of services and programs to help with remediation efforts include:

 

  • FDA Form 483 Response
  • FDA Warning Letter Response
  • FDA Consent Decree Response
  • Import Bans and Notified Bodies Response
  • Independent Third Party Oversight

RCA employs more than 500 industry experts, including FDA, Health Canada, and EU experienced regulatory affairs professionals, to provide support for life science companies. Using our knowledge of food and drug regulations, FDA policy and the pharmaceutical industry, we can help companies overcome unique regulatory challenges. RCA has experience helping pharmaceutical companies respond to FDA warning letters and resolve compliance issues quickly. In one case, we helped a mid-sized company close out a 10-item 483 and subsequent warning letter in six months.

 

Preparing in Advance an FDA 483

RCA also can provide training for the FDA’s Pre-Approval Inspection (PAI) Program before the remediation efforts to help mitigate the situation. Our PAI FDA clients have found this service to enhance their compliance many times over. We adjust all our services to the needs of each client to help ensure the FDA’s concerns are addressed and compliance is achieved. 

 

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. 

 

21 CFR Part 11 Gap Analysis

Background

In preparing for an upcoming 21 CFR Part 11 audit by the FDA, a pharmaceutical chemical manufacturer required a gap analysis. The goal of the chemical products company was to determine compliance of quality and laboratory software to requirements for electronic records.

Challenge

RCA was contracted to perform a gap analysis for software systems used by chemical suppliers. Eight quality management system (QMS system) and twenty-nine lab software systems were analyzed in the chemical factories based in USA.

Approach

Regulatory Compliance Associates® Inc. developed a gap assessment strategy based on each unique chemical manufacturing plant. Client interviews were conducted based on specialty chemical manufacturing and each software system. A gap testing questionnaire was used with each level of manufacturing team member. 

Answers were reached to determine compliance with chemical manufacturing industry standards and specific requirements of Part 11. Then a risk assessment was performed to determine highest risk software systems based on compliance with Part 11.

Finally the gap analysis process prioritized each of the software systems based on the risk analysis. This prioritization was used to develop a data gap analysis and remediation plan to bring all software into compliance.

Result

The final gap analysis document results was presented to the chemical supplier company. It contained a detailed SWOT analysis and software gap analysis to prioritize work needed for the remediation plan. Each production facility had an individual remediation action plan and recommendations to reach regulatory compliance. 

Within a month of the gap assessment, the FDA revisited the client’s corporate headquarters. The Food and Drug Administration reviewed the findings and remediation plans. The FDA determined the client demonstrated a regulatory pathway to eliminate the non compliance. No additional regulatory observation was given and the FDA approved the client was in compliance with 21 CFR Part 11. 

 

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 483 Warning Letters

Background

A mid-sized company received FDA 483 including 10 items of violation. The company responded but subsequently received a Warning Letter. This company was not sure how to best approach the FDA after their first pointed responses resulted in a Warning Letter. They were in need of medical device consultants who could provide insight and expertise. 

Challenge

The FDA clearly set expectations for the manufacturing of drug and device products at this location. The management team had responded to the FDA 483 warning letters once, and was unsure how to respond to the second Form 483.

Approach

Regulatory Compliance Associates® (RCA) developed a phased program plan to address the Warning Letter and the larger quality systems challenges. The first phase provided the FDA with Warning Letter responses with aggressive completion timing and objective evidence detailing the completed commitments.

The second phase of the program assessed and corrected the overall quality system. A comprehensive plan with aggressive but realistic milestones was developed along with supporting tasks and task dependencies. Definition of roles and responsibilities and milestone ownership was determined early on in planning the project.

RCA provided a certified Project Management Professional (PMP) to lead the program, as well as engineers with expertise in quality systems and manufacturing engineering to execute the program in concert with client resources.

Result

The Warning Letter timing, responses, and objective evidence were received favorably by the FDA. The Warning Letter was closed out with the FDA within six months. Best-in-class project management methods employed in Phase II of the program helped to ensure success in achieving quality systems compliance milestones on time and within budget.

 

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. 

 

 

CAPA Processes & Preventative Action

Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their CAPA processes for corrective and preventive action.

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. (RCA) to improve their CAPA System. RCA brought a wealth of knowledge by providing tools, advice and best practices for incorporation into the new draft standard operating procedure (SOP) and CAPA system.

Result

Qualitest is implementing the new SOP and capturing CAPAs in their software tool which collects and analyzes data. The company plans to pursue CAPA certification after obtaining new equipment for the automated software system.

 

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. 

Supply Chain Audit

With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are facing problems keeping their supply chains intact. In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Regulatory Compliance Associates (RCA) Distinguished Fellow and Parental Drug Association (PDA) Chair-Elect, discuss the problems these companies are facing.

Listen in as we go over supply chain audit effectiveness and oversight of service providers. We break down the different ways companies can work virtually to get audits done successfully. The challenges with recording audit findings and conducting interviews. What companies can do to audit suppliers and maintaining their supply chains. As well as answer the questions; is virtual auditing going to be a long term solution, and what companies can do to maintain oversight of service providers.

 

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.