GMP Fundamentals – A Step-by-Step Guide (book)

This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previous acquired knowledge.

Some topics are:

• GMP: Purpose and basic pharmaceutical terms
• Laws, licenses and inspections
• Personnel: Responsibility and hygiene
• Standard Operating Procedures (SOP) and documentation
• Design of rooms and facilities
• Processing and packaging
• Quality control and market release
• Suppliers, storage and logistics (Good Distribution Practice = GDP)
• Alphabetical index and abbreviations

Using practical examples and comparisons to every-day life will help to easily understand GMP regulations.

GMP Fundamentals is a helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.