Saturday, 23 November 2013

15 Years in Pharmaceutical Microbiology


How has the pharmaceutical microbiology arena progressed over the last 15 years? In a review of some major hurdles and milestones, the American Pharmaceutical Review has interviewed some leading microbiologists including Donald Singer (Global Lead Quality Manager, Microbiology, GlaxoSmithKline) and Luis Jimenez, Ph.D. (Biology and Horticulture Department, Bergen Community College).

For example, Donald Singer notes:

"In Microbiology, some milestones I can note:
  • Regulatory scrutiny of sterile products manufacturing has continued to increase and has led to guidance requirements for risk rationale; for example, the rewrite of 21CFR612 for sterility testing, the FDA Guideline for Container Closure Integrity in lieu of Sterility Testing, the MHRA ‘GMP’ Annex 1 pre-fi ltration bioburden action ‘limit’, and the USP <1116> contamination recovery rate recommendation
  • Alignment of regulatory guidance with ICH Quality standards Q7, Q8 and Q9 which impact microbiological risk
  • Increased published articles and books about pharmaceutical microbiological control
  • Forums and media for communicating microbiological issues and solutions have increased Some hurdles I have seen are:
  • Diffi culty in the implementation of new alternative methodologies and concern regarding ‘equivalency’ to pharmaceutical standard methods
  • Economics leading to Microbiology labs to lean staffi ng, less capabilities, less time to innovate, and concern for improvement of supervision of analytical teams that lack experience or suffi cient knowledge in the fi eld
  • Increase in instrument-based technology jumped ahead of adequate education for users to make good scientifi c decisions
  • Continuation in pockets of the industry where management lacking scientific knowledge oversee microbiology operations."
To read more of what they have to say, see APR.



Posted by Tim Sandle