Fundamental information about Good Manufacturing Practices…
GMP literature about facilities and equipment, pharmaceutical water, …
GMP literature about manufacturing, packaging, …
Significant GMP information about qualification and validation…
GMP literature about risk management, inspections, laboratory controls, pharmaceutical quality systems, …
Crucial GMP guidelines and regulations…
GMP literature about microbiology, biopharmaceuticals, medical devices…
Qualification / Validation
Introduction and terminology, legal aspects (USA, Europe, ...), System life cycle, ...
A Drugmaker‘s Guide
NEW ++ NEW ++ NEW
This pocket guide combines the most important laws and GMP guidelines from the USA and Europe.
This book provides practical information to enable compliance with computer infrastructure requirements including the verification activities related with the design and deployment.
A Guide to Risk-Based Validation and Implementation Strategies