USA/FDA

Regulatory Expectations for the Pharmaceutical Industry

GMP Pocket Guide Volume 2
- 21 CFR Part 11 Electronic Records, Electronic Signature
- PIC/S PI 011 Good Practices for Computerised Systems in Regulated ”GxP“ Environments
- EU-GMP-Guideline Annex 11 Computerised Systems

GMP Pocket Guide Volume 3
Definitions of GMP terms – easily explained.

THE reference book of GMP terminology for newcomers and experts!