Here is a comprehensive, easy-to-use reference designed to simplify and enhance understanding of most of the current GMP expectations and how they apply to ongoing manufacturing tasks.  This guidebook will help you make high-quality, well-informed decisions that contribute to a product`s safety, identity, strength, purity, and quality; decisions in keeping with the intent and spirit of GMP.

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

Medical Books

James L. Vesper

Pharmacology

PDA/DHI

Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do follow certain methods?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth edition, Revised and Expanded. As companies strive to harmonize global requirements for quality systems, the 5th edition of this text provides an overview of the 34 essential global cGMP requirements that are typically included in a modern pharmaceutical quality system, including data integrity and how they have evolved. Explore risk-related questions, delve into several expectations for each quality system element encompasses, and review real-world examples from cGMP regulations from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH). If you're looking for an enhanced understanding of GMP in practice, this text is a must-have for your reference collection.

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition Revised & Expanded

Tim Sandle

Reference

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Books by James L. Vesper