GMP Subject Downloads

This excerpt from the GMP MANUAL deals with the main subjects in Laboratory and Analytical Controls.

Apart from the describing content you will find many tables, examples, forms, which can be used in the daily practice.

Table of contents:
- Sampling
- Reagents
- Standards and reference substances
- Qualifying laboratory instruments
- Calibration in the lab
- Validation of analytical methods
- Stability testing
- Out-of-specification results
- Raw data documentation
- Batch release
- Microbiological testing


content Laboratory & Analytical Controls.pdf

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Ralph Gomez, Consultant, USA
Michael Hiob, Ministry for Health of Land Schleswig-Holstein, Germany
Josef Künzle, Basilea Pharmaceutica International Ltd., Switzerland
Bernd Schreiber
Hanfried Seyfarth, retired since August 2005 from Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Excerpt from the GMP MANUAL

PDF file for Download