Where do the contaminants come from? 1. Oils are used as lubricants in the compressors. 2. Water is present naturally in the air in the…
Category: QualityManagement
The final article (really) in Identifying And Resolving Errors, Defects, And Problems Within Your Organization — a series on operationalizing proper improvement techniques Welcome to the sixth…
You might expect the FDA still makes most of its biopharmaceutical site inspections at manufacturing facilities located in the U.S. You (okay, me) would be…
This article represents the fourth year I have published an evaluation of FDA warning letters associated with data governance and data integrity deficiencies. (Here are…
Annex 15 of the EU GMP Guidelines defines “change control” as: “A formal system by which qualified representatives of appropriate disciplines review proposed or actual…
Today, ASTM standard E2500, Specification, Design, and Verification of Pharmaceutical and Bio-pharmaceutical Manufacturing Systems and Equipment,1 elevates risk-based validation as a critical aspect of GMP manufacturing, based…
General Principles (2.1) The design and execution of formal stability studies should follow the principles outlined in the parent guidance. The purpose of a stability…
ICH Q7 expects dedicated production areas for highly sensitizing materials such as penicillins and cephalosporins because of the patient risk (e.g., anaphylactic shock to penicillin-allergic…
Currently, biopharmaceutical companies are striving to produce biologics more efficiently, with a lower cost point and fewer people. Most small-scale media and buffer operations are…
There is no shortage of guidance for conducting extractables and leachables studies. For instance, U.S. Pharmacopeia and the Product Quality Research Institute (PQRI) offer separate…