This hand book 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 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.
Christine Oechslein
GMP GMP Fundamentals Good Manufacturing Practice