In the critical field of pharmaceutical manufacturing, where patient safety is paramount, the strength of our engineering teams is not just a matter of efficiency or productivity—it’s a matter of life and death. As leaders, our approach to building and nurturing these teams directly impacts the quality of our output and, ultimately, the safety of […]
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In the fast-evolving world of pharmaceutical manufacturing, we stand at a crossroads where tradition meets innovation. As an industry, we are custodians of health, holding the safety of patients firmly in our hands. This immense responsibility, I believe, is shouldered not just by the meticulous processes we uphold but significantly by the manufacturing staff who […]
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In the fast-paced world of pharmaceutical manufacturing, ensuring regulatory compliance and maintaining data integrity are crucial for success. That is why finding the right Commissioning, Qualification, and Validation (CQV) partner is essential. This blog explores the key factors that pharmaceutical manufacturers should consider when seeking a CQV provider to establish robust data governance practices. Establishing […]
Read MoreSeptember 2016, I blogged about the draft FDA Guidance Facility Definition Under Section 503B of the FD&C act. In May 2018, the draft guiance was approved and published in the Federal Register and is available here. Industry Questions: FDA has been asked whether an outsourcing facility can create a separate area within its facility for compounding according to […]
Read MoreThis year’s theme for the ISPE 2018 Annual Meeting and EXPO is Vision to Reality: Delivering Next Generation Therapies. One of the frequent challenges when delivering next generation therapies is available manufacturing space. Either the existing facility is committed to current products with no excess capacity, or the time/cost to reconfigure the existing facility to meet […]
Read MoreIn a recently posted FDA Warning Letter, USFDA provided a clear expectation concerning the purpose of validation: The purpose of validation is to determine whether your processes can operate within established parameters to assure consistent batch uniformity, integrity, and drug quality. Reliable and well-documented batch operations are essential to ensuring process control and drug quality. The firm […]
Read MoreWhat are the top 5 citations from FDA inspections for the past 3-years (2018-2020)? #1 For each of the past 3-years 21 CFR 211.22(D) has been the most frequent observations in FDA inspections. The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. According to […]
Read MoreOver the past few years, I have read hundreds of FDA warning letters. A common observation that I wanted to share was the apparent difference in perceptions between the inspected organization and the FDA. My opinion is that in most cases, the inspected organization takes the FDA findings for this instance in time and often […]
Read MoreIn a recently posted warning letter, a drug manufacturer was cited for receipt and delivery of adulterated drugs. As cited in the warning letter: We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your […]
Read MoreA common observation during FDA inspections is a failure of the drug company to perform incoming testing of raw materials and relying solely upon the suppliers CofA. A common misconception is that I can simply accept the CofA from my supplier with no testing or qualification of the supplier. This is not acceptable per the […]
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