Reading Samples
See for yourself how GMP MANUAL provides you with state-of-the art GMP know-how that will simplify your daily business!
Table of Contents
Reading Samples
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
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Computer Validation
Pocket Guide Volume 2
Auflage: 2nd edition 2011
Format: 140 x 105 mm
ISBN: 978-3-934971-97-4
Format: 140 x 105 mm
ISBN: 978-3-934971-97-4
€ 25,00
netto
€ 26,75
inkl. 7% MwSt.
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The validation of computerised systems is important in most pharmaceutical areas.
This pocket guide combines the most important laws and GMP guidelines from the USA and Europe.
Table of contents:
- CFR Title 21 Part 11, Electronic Records, Electronic Signatures
- PIC/S Guidance PI 011 Good Practices for
computerised Systems in regulated "GxP" Environments
- EU-GMP-Guideline Annex 11 Computerised Systems (January 2011)
- Index
This pocket guide combines the most important laws and GMP guidelines from the USA and Europe.
Table of contents:
- CFR Title 21 Part 11, Electronic Records, Electronic Signatures
- PIC/S Guidance PI 011 Good Practices for
computerised Systems in regulated "GxP" Environments
- EU-GMP-Guideline Annex 11 Computerised Systems (January 2011)
- Index
