国际药学与生命科学研究与发展杂志

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THE ROLE OF REGULATORY GMP AUDIT IN PHARMACEUTICAL COMPANIES

Sumit Kumar, Deepika Tanwar, Nageen Arora

The goal of an audit is to express an opinion on the person, organization, system etc. in question, under evaluation based on work done on a test basis. Audits are performed to ascertain the validity and reliability of information; also to provide an assessment of a system's internal control. A company that makes medications today must be able to prove that it does so with absolute reliability, under optimal secure conditions, and with extreme uniformity to allow for exact reproduction. Pharmaceutical auditing expertise includes writing and review of validation policies, guidelines and SOP from design qualification to performance qualification steps.