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 authoriti

GHTF Study Group 3 - Quality Systems Process Validation Guidance Draft – February, 1999 Page 3 1 Purpose and scope 1.1 Purpose This process validation guidance is intended to assist manufacturers in understanding quality system requirements concerning process validation.

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