Validation of Microbiological Tests - - BioPharm International

ADVERTISEMENT

Validation of Microbiological Tests


BioPharm International


Suggested Reading Carroll MC. A multifaceted look at the microbial limits test. In: R Prince, editor. Microbiology in Pharmaceutical Manufacturing. Baltimore, MD: PDA; 2001. pp. 519–535.

PDA. Evaluation, validation and implementation of new microbiological testing methods: PDA Technical Report No. 33. PDA Journal of Pharmaceutical Science and Technology 2000; 54(Suppl. TR33).

Petitti DM. Practical considerations for the development, validation, and transfer of analytical test methods. In: R Prince, editor. Microbiology in Pharmaceutical Manufacturing. Baltimore, MD: PDA; 2001. pp. 723–746.

Steven S. Kuwahara, Ph.D., is the principal consultant and founder of GXP BioTechnology LLC, PMB 506, 1669-2 Hollenbeck Avenue, Sunnyvale, CA 94087-5042, 408.530.9338,
.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Novartis and GSK Trade Assets
April 22, 2014
Lilly to Acquire Novartis Animal Health
April 22, 2014
EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
Author Guidelines
Source: BioPharm International,
Click here