21 CFR 211
Difference Between 21 CFR Part 11 and EU GMP Annex 11
Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Here’s why they’re non-negotiable: Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences. Compliance ... Read More
Frequently Asked Questions and Answers on cGMP
Q1. Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? The CGMP regulations for finished pharmaceuticals require the retention of cleaning and use logs for non-dedicated equipment. But no similar requirement exists for retaining what are intended to ... Read More
Subpart of 21 CFR Part 211
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. FDA 21 CFR Part 211 covers the areas for finished drug products, such as labeling, production processes, equipment management and ... Read More
Inadequate Investigations: A Common Observation by the FDA
During cGMP inspections, one of the most commonly cited observations by the FDA is the inadequate investigation into deviations. Pharmaceutical companies must address this issue to maintain compliance and ensure patient safety. Here are some key points to keep in mind regarding deviation investigations in the pharmaceutical industry: Observation Highlight ... Read More
Walking Through the 21 CFR Part 11
If you are connected to the life sciences industry in one way or another, you have undoubtedly heard of the United States Food and Drug Administration’s (FDA’s) 21 Part 11 Regulation. We begin by decoding 21 CFR Part 11 itself: The CFR is organized like this: Title > Chapter > ... Read More
Vendor Qualification Under FDA and ICH Regulations
FDA, Guidelines, ICH
All contract service organizations and vendors who supply the cGMP facility with critical supplies, reagents, and equipment must be qualified. This helps to ensure all products have been manufactured in a way that prevents the introduction of adventitious agents or toxic impurities and ensures final product safety, effectiveness, and consistency. ... Read More