MDSAP Audit Approach (MDSAP AU P0002)
Chapter 6: Production and service controls – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C6-T4: Set documented product cleanliness requirements (including before sterilisation and for non-sterile supply) and removal of process agents, with pest control and housekeeping for Brazil

What does C6-T4 require?

Documented requirements must cover product cleanliness, including cleaning before sterilisation, cleanliness of product supplied non-sterile and removal of process agents where required. Brazil: a pest control programme must exist, with chemicals that do not affect product quality, and housekeeping procedures and schedules must cover production areas and warehouses (RDC 665/2022 Arts 69 and 74). Clauses: ISO 13485:2016 4.2.1, 4.2.3, 6.4.2, 7.5.2; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(d); RDC 665/2022 Arts 69, 75, 79; MO169 Arts 6, 7-2, 25-2, 41.

Maintained by Gerard Blokdyk

Other controls in Chapter 6: Production and service controls – MDSAP Audit Approach (MDSAP AU P0002)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll MDSAP Audit Approach (MDSAP AU P0002) controls