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For Immediate Release (Indianapolis, Indiana August 22, 2017). Performance Validation (PV) is pleased to recognize Ms. Jackie Eysol’s certification as an American Society for Quality Certified Quality Auditor (CQA). Jackie is a Senior Validation Engineer with Performance Validation. A Senior Validation Engineer is responsible for demonstrating a sound knowledge, application, and proper implementation of technical, quality […]
Read MoreFY 2016 Drug Inspection Summary
FY 2016 Drug Inspection Summary From October 1, 2015 to September 30, 2016, 691 Form 483’s were issued to Drug Manufacturers, which resulted in 3,342 individual citations. The frequency of citations ordered by subpart of 21 CFR 211 provides the following insight as to inspection trends identified by FDA for Fiscal Year 2016. As you can […]
Read MoreFY 2015 FDA Inspection Summary
FDA Inspection Trends, FY 2015 Did you know that in FY 2015 the US FDA completed 5,615 GMP inspections of registered drug and device establishments? The total number of inspections has decreased by 6.3% since FY 2013. However, the number of foreign inspections as a percent of total inspections per fiscal year have risen from […]
Read MoreFDA Warning Letter to OTC Manufacturer
In a recently posted FDA warning letter to OTC Manufacturer, the OTC manufacturer in Canada received 6 observations. This is one of the few warning letters where FDA calls out executive management for failure to provide oversight and control of drug manufacturing. The OTC firm had promised actions from prior inspections – but failed to implement […]
Read MoreFDA Regulation and Inspection Guide
Are you a 503B trying to understand the FDA Regulation and Inspection Guide? Do you feel like these guys? I have a limited number of FDA Guidebooks that contain the FDA regulations 21 CFR parts 210 and 211 cGMPs in Manufacturing, Processing, Packing, or holding of drugs and finished pharmaceuticals AND the Drug Manufacturing Inspections: […]
Read MoreFDA Proposed Rule for a GLP Quality System
Those of us who have worked in pharmaceuticals or medical device are familiar with the concept and requirements of a Quality System. On August 24, 2016, the FDA issued a proposed a rule to the Good Laboratory Practices (GLPs, 21 CFR part 58), titled “Good Laboratory Practice for Nonclinical Laboratory Studies”. The concept is akin to […]
Read MoreFDA Funding
On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety: The practice of compounding medicine can provide important public health opportunities. The FDA’s […]
Read MoreFDA Devices Inspection Summary – FY 2013
A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of Devices. From 10-1-12 to 9-30-13 approximately 1099 device 483’s were issued and a total of 4393 citations were referenced. This is approximately the same number of 483’s that were issued in 2012 (N=1090), however the number of citations referenced in […]
Read MoreFDA 2018 Compounding Policy Priorities
January 2018, FDA Commissioner Scott Gottlieb issued the FDA 2018 Compounding Policy Priorities Plan on the FDA website. This communication provides a summary background on how the FDA became involved in compounding pharmacies, and a summary of how FDA will prioritize actions to protect the public health as obligated under DQSA. I found the following section particularly interesting: […]
Read MoreDid We Validate The System’s Intended Use?
If you are wondering whether the validation you are working on has covered the appropriate functionality, consider one of the primary criteria cited by the FDA for validating is the intended use of the software which is used as part of the production and/or quality system . Over the last ten years, numerous FDA Form […]
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