GMP in Microbiology and Biotechnology

Microbiological Assay is defined as the determination or estimation of concentration or potency of an antibiotic by means of measuring and comparing the area of zone of inhibition or turbidity produced by test substance with that of standard over a suitable microbe under standard conditions. FDA 510k Testing regulation is found in 21 CFR 807 includes information required in a 510(k). The 510(k) is not a form. Cleaning, disinfection and hygiene should be strictly maintained in Microbiology and Biotechnology.

Pharmaceutical microbiology laboratories may be involved in as part of the test system. GMP guidelines relate to all microbiology laboratories involved in sterility testing, detection, isolation, enumeration and identification of microorganisms and testing for bacterial endotoxins in different materials, products and assay using microorganisms whether they are independent or a department or unit of a pharmaceutical manufacturing facility.  GMP in biotechnology  mandate specialized training and lab environmental controls such as instructions for ensuring freedom from vermin, instructions for how to build and maintain clean rooms, directives on how to house and handle lab animals, and strict policies for compliance.

  • FDA 510k testing
  • Contamination control, cleaning, disinfection and hygiene
  • Qc in microbiology lab
  • Sterility assurance and sterility testing
  • Microbial assays
  • Validation of microbial recovery

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