A Quality Systems approach to GMP auditing has become common practice among both regulatory authorities and internal GMP audit programs at pharmaceutical companies. The approach began with the CDRH QSIT Inspection paradigm and was adopted by CDER and CBER for pharmaceutical drug inspections. The FDA Guide to Inspections of Quality Systems published in August 1999. In September, 2006, CDER, CBER, ORA and CVM published Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations. The pharmaceutical inspection approaches rely on the evaluation of several or all components of the Quality Systems: quality, production, laboratory, materials, facilities & equipment, packaging and labeling. FDA deems that if one ‘system’ is out of compliance then all may be deemed to be out of compliance. This approach provides structure for internal audits, supplier / contractor qualification and monitoring, due diligence efforts and agency inspections. It does, however, have serious limitations when it comes to the assessment of data management and data integrity.
Routine quality system approach to auditing can frequently fail to identify data management and data integrity problems. As an example…READ MORE