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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2015)

Effective GMP AUDITS for APIs and Formulation Pharmaceutical Companies

G Sunder

Introduction: The independent third-party GMP audit is to evaluate GMP compliance status of the manufacturer in accordance with the current GMP requirements set forth in 21 CFR Part 210 & 211 ICH Q7 and EU GMP with its interpretations. The compliance status will be evaluated in terms of Quality compliance with respect to all the six systems and hardware, software, and personnel. All deficiencies identified during the cGMP audits will be noted in the audit report with gap analysis and proposed corrective actions. A pharmaceutical auditing plan may include CAPA on:

  

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