ABSTRACT
The pharmaceutical microbiologist has an important role in product development, manufacturing process development, ensuring control of microorganisms in the manufacturing environment and routine raw material, in process material, and product testing. The quality control unit must have access to an adequate testing laboratory to aid in the approval of the materials under its control. One of these laboratory facilities would be suitably equipped and staffed to conduct microbiological testing. The quality control unit need not manage the microbiology laboratory. The compendial microbial methods currently used for the routine testing of pharmaceutical products are generally conservative and may be used to referee disputes concerning the microbial contamination of pharmaceutical products. The microbiological monitoring program established at a pharmaceutical manufacturing site will depend on the range of products manufactured there. A common practice in microbiological testing is that pharmaceutical ingredients and products are tested without full consideration of their significance.
