MDSAP Audit Approach (MDSAP AU P0002) A2-sterile: Control every process contributing to sterility through the QMS, with validated and revalidated processes, routine monitoring, batch records, designated lot release and controlled sterilisation and laboratory suppliers

What does A2-sterile require?

For sterile devices the organisation must control through its QMS all processes that contribute to sterility (design for sterilisation compatibility, cleaning and disinfection, aseptic processing, sterile barrier packaging, terminal sterilisation, environmental control and storage), complete validation where applicable and define revalidation criteria (periodic, after significant changes or trends), run processes within validated parameters with routine environmental and cleanliness monitoring, achieve consistent batch results, keep a batch record for each sterilisation batch to an approved master record, release each lot by a designated person under a procedure, and control outsourced sterilisation and laboratory service suppliers (selection, agreements, audits). Sterility requirements are audited at least once per certification cycle and on site.