MDSAP Audit Approach (MDSAP AU P0002) C6-T7-T8: Identify the processes (including outsourced ones) that need validation and validate them under documented procedures, with revalidation after changes and methods reflecting the state of the art

What does C6-T7-T8 require?

The organisation must review production processes and sub-processes, including outsourced ones, to decide which need validation, and must validate under documented procedures any process whose output cannot be, or is not, fully verified, showing it consistently achieves planned results and re-reviewing and revalidating after changes. Australia: validation methods must reflect the generally accepted state of the art (for example Medical Device Standards Orders, ISO and IEC standards and pharmacopoeias) (TG Act s 41CB; EP 2(1)). Brazil: analytical methods and the auxiliary production and environmental control systems that could affect quality must be validated, periodically reviewed and revalidated as needed (RDC 665/2022 Arts 103 to 106). Clauses: ISO 13485:2016 4.1.6, 4.2.1, 7.5.6; TG(MD)R Sch 1 Pt 2 EP 8.2, 8.3, Sch 3 Pt 1 cl 1.4(5)(d); MO169 Arts 5-6, 6, 45.