MDSAP Audit Approach (MDSAP AU P0002) C3-T6-T7: Evaluate new hazards and risks from CAPA-driven design or process changes, revalidate processes where needed, and notify regulators, auditing organisations or MAHs of significant or critical changes

What does C3-T6-T7 require?

When a corrective or preventive action changes the design, any new hazards and risks must go through risk management; when it changes a process, the change must be assessed for new product risks and the process revalidated where appropriate. Australia: the procedure for substantial changes to critical processes (such as sterilisation, processing materials of animal, microbial or recombinant origin, or incorporating a medicinal substance) must require the manufacturer to notify its auditing organisation before implementation so it can confirm the conformity assessment procedure is still met, and to notify the TGA as well if it holds a TGA conformity assessment certificate (Sch 3 Pt 1 cl 1.5(2)). Canada: a process must identify significant changes to Class III or IV devices for licence amendment (CMDR 1, 34). Japan: a Registered Manufacturing Site must tell the marketing authorization holder before significant manufacturing process changes such as a sterilisation or manufacturing site change (MO169 Art 29). Clauses: ISO 13485:2016 4.1.4, 4.1.6, 7.1, 7.3.9, 7.5.6, 7.5.7.