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The 2023 Compliance Issue: Addressing the Top-Cited CFRs to Pharma and Device Firms + Warning Letter Breakdown

We take a close look at most frequently cited CFRs to drug and device firms throughout FY2022 and break down two recently issued Warning Letters.

Welcome to Insider issue #13.

And welcome to the 125 new life science professionals who joined last month.

In this month's "Compliance Issue," we offer insights from the field to ensure GMP compliance in the most frequently cited CFRs for the fiscal year 2022, covering both the pharmaceutical and medical device industries.

For the pharmaceutical sector, we concentrate on the responsibilities of the Quality Control Unit, general laboratory control requirements, and production record review. In the medical device industry, we emphasize the significance of CAPA procedures, complaint procedures, and purchasing control procedures.

Our aim here is to help you identify potential gaps in your processes and offer valuable tips to reinforce your compliance efforts by examining these commonly cited regulations. We discuss the importance of defining and documenting responsibilities, nurturing partnerships between quality control and operations, allocating adequate resources, and ensuring processes are grounded in sound scientific principles. Additionally, we explore strategies for managing discrepancies, failures, and investigations, as well as maintaining compliant CAPA, complaint, and purchasing control systems.

Finally, we dissect and derive lessons from recent FDA Warning Letters issued to two foreign medical device companies for multiple violations. We analyze their shortcomings and provide key takeaways to prevent similar issues. These case studies serve as cautionary tales, underlining the importance of regulatory compliance, quality audits, and continuous improvement in the global marketplace.

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