Internal Audits For Pharma And Biotech

By Michael J. Gregor, President, Compliance Gurus Inc.

An internal audit or also known as a quality audit says in 21 CFR 820: "Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented." I would like to make an important point that although this is a Quality System Regulation requirement, the need for internal or quality audits are also necessary in the pharmaceutical drug, biological drug, food, cosmetic, and dietary supplements industries.

Used with permission from Life Science Leader magazine.