Enterprise Resource Planning (ERP) validation is a critical step for FDA-regulated industries, to ensure compliance with regulatory requirements and industry standards. This process ensures that the ERP system accurately and consistently tracks and records critical data, such as product information and manufacturing processes. In this blog post, we will discuss why it is necessary to […]
Read MoreIn early 2019, the Washington State Legislature passed HB-1257, the Washington Clean Buildings Performance Standard, into law. The legislature requires that the majority of facilities greater than 50,000 gross square feet will need to meet or exceed a prescriptive energy usage target based on the type of facility, with the largest buildings needing to comply […]
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 MorePerformance Validation recently featured an introductory post on risk-based computer system validation. It is an approach by which one can focus the validation effort on critical business and regulatory requirements and reduce the need for excessive testing and redundancy. A fundamental aspect of this approach is to leverage software vendor functional testing. This permits the […]
Read MoreThere are a number of industry regulations from all around the world that explicitly and implicitly require temperature mapping as a documented process to demonstrate adequate temperature conditions are maintained for storage of temperature-sensitive pharmaceutical products. However, most of those regulations provide little guidance as to the specifics on how an appropriate temperature mapping should […]
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 […]
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