Client

A combination product manufacturer received an FDA 483 warning letter for a facility that produces a branded prefilled syringe (PFS) drug delivery system with manual needle guard, vial and vial adapter, and auto injector.

 

Project Timeline

Gap Assessment – 2 weeks

Remediation – 3 months per DHF technical file

 

Client Challenge

RCA’s client unsuspectingly received a warning letter for violating regulatory standards (e.g. 21 CFR 3, 21 CFR 820) after a bi-annual FDA inspection revealed new 483 observations had occurred. Specifically, FDA regulators cited the medical device portion of the combination product was no longer following current good manufacturing practices (cGMP). Further, technical documentation required for regulatory compliance was noted as either missing or mislabeled by the Quality Assurance (QA) team in charge of the quality management system (QMS).

 

Regulatory Compliance Associates Approach

RCA’s combination product consulting team laid out a detailed strategy for bringing the client’s operation back into compliance. A gap analysis discovered multiple manufacturing departments with a younger team needed refresher training to review QA best practices. Additionally, the data revealed a growing decline of compliance resources for supporting the internal team – which began a planning discussion about optimizing the manufacturing team headcount. 

 

Design Controls

RCA consultants began the process of reviewing existing technical documentation in the QMS folders and found multiple gaps for remediation. Additionally, the team knew implementing updated and compliant procedures for design validation was critical to address early in the project. One of the 483 observations listed in the warning letter was a failure to show how proposed actions will be incorporated into the consumer complaint process due to design validation problems.

 

Design Control Process

First, an updated design control process was developed to improve all existing design procedures as a whole. The goal of the process improvement strategy was to define user needs more clearly so regulators could validate the accuracy of production testing methods for components. Additionally, new technical documentation was needed to show the results of testing current production units under both actual conditions and simulated conditions.  

 

Remediation Services

During the gap assessment, RCA’s consulting services team established the need to streamline information in the client’s design history file. The RCA manufacturing consulting team developed an updated annual requirement for design changes and SOP review. This included updating the SOP procedures for product design (e.g. identification, documentation, and validation) for approval and before implementation (per 21 CFR 820). Finally, a corrective action and preventative action (CAPA) program was launched to ensure the client operations team would have the necessary technical documentation in place to confirm these SOP improvements could be measured in real time. 

 

Quality Assurance

RCA’s quality assurance services team simultaneously supported the project by conducting validation studies to help define the actual use conditions of the combination product. These were critical to executing since the 483 observations noted “minimal information in the design history file” to help identify prescribed user needs or the product’s intended use.

 

Results

The client’s regulatory response improved the internal expectations needed by employees on the manufacturing operations team. The CAPA program was formally approved by the FDA and helped establish a standards process with both leadership accountability and team visibility. Finally, the client’s facility returned to full compliance approximately fifteen months after the project began.

 

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. 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

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

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

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.