2014
saw a number of important regulatory changes impacting upon pharmaceutical
microbiology.
These
have included:
- New cleanroom monitoring draft standards
- EMA guidance on analytical method validation
- EU GMP chapters on validation and qualification
- International agreement on endotoxin testing
- USP guidance chapter on depyrogenation
Tim
Sandle has written a review of these key changes for European Pharmaceutical
Review. The reference is:
Sandle,
T. (2014) Review of regulatory changes impacting on pharmaceutical microbiology,
European Pharmaceutical Review, Issue
6, pp37-40
Posted by Tim Sandle
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