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GMP Quality Assurance

Laboratory & Analytical Controls
€ 99.00
net
€ 117.81
  19% VAT included
PDF-Download
US$
149.00
This title deals with the main subjects in Laboratory and Analytical Controls.
215 Pages
ISBN: 978-3-943267-20-4
   x
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

Please note the following procedure guidelines:

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  • The invoice will be sent by postal mail as soon as possible.

Technical Requirements

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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
Recommendations
Computer System Validation in the EU
Managing Contract Manufacturers and Testing Labs

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