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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.
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GMP fundamentals, Christine Oechslein
- Language
- Released
- 2015
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- Title
- GMP fundamentals
- Language
- English
- Authors
- Christine Oechslein
- Publisher
- Maas & Peither, GMP Publ.
- Released
- 2015
- ISBN10
- 3943267423
- ISBN13
- 9783943267426
- Category
- Health / Medicine
- Description
- 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.