GMP Fundamentals

Beschreibung

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.

Autor*in

Christine Oechslein

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Good Manufacturing Practice (GMP) Pharma Quality Assurance Quality Management Regulations

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