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Microbiologist.in
Pharma QC microbiology, in your pocket
Investigate OOS, OOT, excursions and deviations in the micro lab the way inspectors expect: phase 1 and 2, retesting rules, root cause tools, CAPA, reports and real cases.
Anyone who investigates or approves micro lab failures: analysts, reviewers, QA and lab heads.
Yes, after the lessons and a 25-question final test (pass mark 70 %), with a QR verification page.
The Barr decision, FDA OOS guidance (2006, revised 2022), MHRA OOS/OOT guidance, EU GMP Chapter 6, Schedule M and the pharmacopoeial sterility test invalidation rules.