Module 14 2022

Manufacturing & Process Validations

• Full manufacturing validations are required (MDR Annex II, Section 3b)

• Protocols & reports of critical process validations are required, not just summary • Overall summary / Master Validation Plan helpful to understand overall strategy and process • Clear link between PFMEAs, manufacturing processes, incoming inspections and inline tests etc. for completeness and control. • Process validations: what was run, including justifications for tests conducted, sampling rationale, raw data, product range covered.

The Organisation for Professionals in Regulatory Affairs