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, stevekuwahara@yahoo.com
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