Monday, 3 September 2018

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry


The fifth edition of the book "GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry" is now available, at a special introductory price. 

The book is written by James Vesper and Tim Sandle. 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). See: https://store.pda.org/ProductCatalog/Product.aspx?ID=4511

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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