How Is Equipment Qualification Assessed During Drug Quality Audits In Japan?

During drug quality audits in Japan, equipment qualification is assessed by reviewing documentation for design, installation, operational, and performance qualifications (DQ, IQ, OQ, PQ). Auditors verify compliance with Good Manufacturing Practices (GMP), ensuring equipment consistently produces quality products. Calibration records, maintenance logs, and validation protocols are also examined for accuracy and completeness.

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