Transcription of GHTF Process Validation Guidance - Edition 1
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GHTF Process Validation Guidance - Edition 1
GIITFIFD: 99-10 FINAL DOCUMENT Title: " Process Validation Guidance for Medical Device Manufacturers" Endorsed by: The Global Harmonization Task Force Date: lune 29, 1999 Eliza'heth , , GHTF Chair The document herein was produced by the Global Harmonization Task Force which is comprised of representatives from medical device regulatory agencies and industry. The document is intended to provide non-binding Guidance for national competent authorities to use in regulating medical devices. Endorsement by the Global Harmonization Task Force signifies consensus acceptance of the document by principal Task Force members arxl their good faith intent to foster the adoption and implementation of this harmonized Guidance by reguJatory control authorities in their respective regions/ nations.
Process validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed. ... • Sterilization processes • Clean room ambient conditions • Aseptic filling processes • Sterile packaging ...
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