Does Your Quality System Assure Products Are Safe And Effective?

By Christine Park, Quality Architech

21 cfr 211.198 b 2 states
Where an investigation under 211.192 is conducted, the written record shall include the findings of the investigation and follow-up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with 211.180(c)

The Food and Drug Administration (FDA) guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations) references this clause as the basis for management review activities.  The Q10 Guideline, published by International Conference for Harmonization (ICH) provides greater prescription and detail regarding the expectations of management review for the pharmaceutical quality system.  Regardless of which reference document you use, a systemic review of the quality system activities is key to assuring continued suitability and effectiveness.