GMP-Inspektionen und -Audits 3. Auflage

German, Michael Pfeiffer, Bettina Pahlen, Jörg Fetsch, Gerhard Becker, Thierry P. Dietrich, N Spieggelkötter, Frank Concept Heidelberg, B Pahlen, G Becker, T P Dietrich, M Pfeiffer, R Schulze, H Prince, J Fetsch, 2020
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Fundamentals - Regulatory Inspections - Practical Reports - Audits in a Global Context

What matters: GMP inspections and audits are an essential component in ensuring the quality of pharmaceuticals. Without a successful GMP inspection, there is no manufacturing license, and a GMP inspection is also a prerequisite for the import of pharmaceuticals and certain active ingredients. Renowned experts from industry and regulatory bodies provide a comprehensive introduction to the subject matter and offer practical solutions for daily work. Audit checklists (available for download) complement this Pharmaceutical Technology Journal, serving as template documents and a guiding framework in practice.

New in the 3rd edition 2019: Auditing of data integrity - Inspections of excipient manufacturers - GCP audits - GDP audits - FDA inspections - Audits in China. This scientific series addresses specific topics in pharmaceutical technology in the form of individual volumes. The editions are selected by a scientific advisory board and published by Concept Heidelberg.

Key specifications

Language
German
topic
Technology & IT
Subtopic
Chemical technology
Author
B Pahlen, Bettina Pahlen, Frank Concept Heidelberg, G Becker, Gerhard Becker, H Prince, J Fetsch, Jörg Fetsch, M Pfeiffer, Michael Pfeiffer, N Spieggelkötter, R Schulze, T P Dietrich, Thierry P. Dietrich
Number of pages
200
Year
2020
Item number
35198578

General information

Publisher
Editio Cantor
Category
Reference books
Release date
10.1.2020

Book properties

topic
Technology & IT
Subtopic
Chemical technology
Language
German
Author
B Pahlen, Bettina Pahlen, Frank Concept Heidelberg, G Becker, Gerhard Becker, H Prince, J Fetsch, Jörg Fetsch, M Pfeiffer, Michael Pfeiffer, N Spieggelkötter, R Schulze, T P Dietrich, Thierry P. Dietrich
Year
2020
Number of pages
200
Edition
3
Year
2020

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Product dimensions

Height
241 mm
Width
172 mm
Weight
497 g

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