Derived from the normative standards and based on the corresponding experience with quality management systems (QM systems) in the area of ISO standards 9001, 13485 and 15378, blue offers pure QM system audits. Mock audits of the QM system can, among other things, help manufacturers to prepare for authority inspections. And successfully so: “The audit service definitely supported successful passing of the EU GMP inspection”, reports our client RPG Life Science (India).
GMP audits usually consist of the following elements: system conformity check, product conformity check and regulatory approval conformity check. In real life, it is often difficult to adequately audit all aspects for various reasons such as time limitations, audit scope limitations, missing regulatory approval documents and the like. Heterogeneity in GMP compliance status of manufacturers in particular leads to audits being performed to different levels of depth and requires professional adjustment of audit priorities. This is where the quality management system audit (QM system audit) of blue inspection body comes into its own.