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.

  • 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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