GHTF · International guidance
GHTF/SG3/N99-10:2004
QMS Process Validation Guidance
International Medical Device Regulators ForumGHTF/IMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- GHTF/IMDRF
- Reference
- GHTF/SG3/N99-10:2004
- Published (source metadata)
- January 2, 2004
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About this guidance
QMS Process Validation Guidance
Guidance on process validation requirements for medical device manufacturing. Covers IQ, OQ, PQ protocols and ongoing process verification.