Global Pharmaceutical GMP: Build Once on Principles Every Inspector Shares

Most national GMP rules descend from the same ideas: an independent quality function, written and approved procedures, qualified people, controlled materials, documented production and investigation of anything unexpected. WHO's main principles are used as the basis for GMP in many countries.

21 CFR 211.22 gives the quality control unit responsibility and authority to approve or reject components, containers, closures, in-process materials, packaging, labelling and drug products, and to review production records to make sure no errors have occurred or that errors have been fully investigated. It also requires the unit to approve or reject procedures and specifications.

Section 211.192 requires production and control records to be reviewed and approved by the quality control unit before a batch is released or distributed. Any unexplained discrepancy or failure to meet specifications must be thoroughly investigated, whether or not the batch has been distributed, and the investigation extends to other batches that may be affected.

Section 211.68 allows automatic, mechanical and electronic equipment, including computers, if it performs satisfactorily and is routinely calibrated, inspected or checked under a written programme. Appropriate controls must limit changes to master production and control records to authorised personnel, and input and output must be checked for accuracy.

Keep a register of each market you supply, the GMP text that applies, the date you last checked it and any requirement that goes beyond your base system, such as a named qualified person, local retention periods or specific stability conditions. Assign an owner for each entry.