In 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 […]
Read MoreA review of warning letters posted on September 10, 2013, to the FDA website was conducted. Four of thirteen warning letters were issued by CDRH with a subject of Quality System Regulation for Medical Devices/Adulterated. Twenty-seven violations were identified at these four manufacturers. A break-down of the identified violations follows: Citation […]
Read MoreWhat happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective? In a recent warning letter, FDA identified four citations: While not numbered as an observation, the FDA also commented that the firm does not always follow their current SOPs. Finally – FDA made […]
Read More– Bruce Beck Project information is the data and documentation generated by a number of sources including engineering, vendors, automation groups, contractors and operations as well as the C&Q team over the course of the project. Accurate, complete information in the form of data, documentation and drawings is fundamentally important to not only the project […]
Read MoreWhat happens when a firm obtains out of specification results? 21 CFR 211.192 states: All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy […]
Read MoreEMA released the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container on 6 March 2019, and it will go into effect 1 October 2019. The guideline is available here. This document addresses: 4. General requirements 4.1. Requirements for the manufacture of sterile medicinal products and sterile components 4.1.1. Steam sterilisation 4.1.2. […]
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