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Topic: cGMPs & Regulatory Compliance
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FDA Science and Mission at Risk
PharmaManufacturing.com
This report by the Subcommittee on Science and Technology provides the context within which the FDA operates. The Subcommittee found substantial weaknesses across the Agency, with the possible exception of some drug and medical device review functions funded by industry user fees. There are several areas of greatest concern, however, which form the basis for this report’s most significant findings.
EuroBio Report : A Critical Look at Drug Regulations
PharmaManufacturing.com
Industry experts provide a critical analysis of regulation policy in both the U.S. and Europe at the EuroBio 2007 Show in Lille, France.
From the Editor: Can Your Data Stand Up in Court?
PharmaManufacturing.com
Rumors of 21 CFR Part 11’s demise have been greatlly exaggerated. Data integrity is at the heart of numerous 483s and a recent lawsuit against Novartis.
Washington Letter: FMEA as a Packaging Tool
PharmaManufacturing.com
Failure Modes and Effects Analysis promises to become a more important risk assessment tool for pharmaceutical manufacturing. Could its use be required for labeling and packaging?
White Papers: In Depth Research
Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
Author: FDA Center for Drug Evaluation and Reseacb
Posted: 10/09/2006
This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products.
PAT Answers: FDA's Final Guidance
Author: U.S. Food and Drug Administration
Posted: 10/14/2004
FDA recently released its final guidance on process analytical technology, “PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," as part of its broader 21st Century cGMP initiative.
FDA Goes "Final" with Its 21st Century cGMP Guidance
Author: FDA
Posted: 10/13/2004
FDA's final report on “Pharmaceutical cGMPs for the 21st Century—a Risk-Based Approach” is hot off the press. From aseptic processing to electronic record-keeping to quality systems, get your guidance here.