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TEXT BOOK OF AUDITS AND REGULATORY COMPLIANCE (M.PHARM SEM II)

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Book Details

  • Publisher: PV Books

  • Authors: Dr. Prerna Sharma, Dr. Rageeb Usman, Pranita Shankarattti

  • Language: English

  • Course: M.Pharmacy / Semester II

  • ISBN: 9781543345841

About the Book

This textbook is prepared in accordance with the M.Pharm curriculum and provides a comprehensive understanding of Audits and Regulatory Compliance in the pharmaceutical industry. It covers types of audits, audit planning and execution, regulatory inspections, compliance management, documentation practices, and corrective and preventive actions (CAPA). The content explains national and international regulatory expectations, including GMP compliance and inspection readiness. Presented in a clear, systematic, and postgraduate-oriented manner, the book is highly useful for regular study, revision, research orientation, and semester examination preparation for M.Pharmacy students.