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1.B The road to a pharmaceutical quality system
Extract: 7.A Process Validation - Official Requirements
Extract: 18.H Questionnaire for preparing GMP inspections
19.B.3 The qualified person - Qualification and Experience
21.A.11 GMP for APIs - Laboratory Controls
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ICH Q8, Q9, Q10
GMP Pocket Guide Volume 4
Auflage: 1st edition 2010
164 Seiten
ISBN: 978-3-934971-75-2
164 Seiten
ISBN: 978-3-934971-75-2
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The ICH guidelines Q8, Q9 and Q10 represent the current thinking in the development of quality systems in the pharmaceutical industry. These guidelines are not binding but they trigger the ongoing discussions to improve the quality systems and procedures in the pharmaceutical industry. The knowledge about the contents of ICH Q8, Q9 and Q10 is a must for every responsible person in the quality and GMP area of a pharmaceutical company.
Contents:
- ICH Q8 Pharmaceutical Development
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- Index
Contents:
- ICH Q8 Pharmaceutical Development
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- Index
API and pharmaceutical manufacturers, consultants
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