Quality Management System Audits

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.

Advantages of a QM system audit

QM system audit offers the auditee the perfect opportunity to:

  • verify the internal quality level against that of external partners;
  • implement continuous improvement measures beyond self-inspections;
  • prepare for inspections conducted by the authorities;
  • win clients by independent proofs of quality.

Getting granular on GMP

Audits self-initiated by the auditees focus on GMP compliance of the quality management system. After checking the pre-defined GMP system process procedures projected for submission, an on-site audit is performed. This audit verifies the proper implementation of GMP system process procedures by random system-specific and product-specific samples.