Thursday, 1 January 2015

Regulatory changes impacting on pharmaceutical microbiology


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

The article can be accessed for free (although registration is required for the website) here.

Posted by Tim Sandle