Transcription of GHTF SG3 - QMS - Process Validation Guidance -January 2004
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GHTF SG3 - QMS - Process Validation Guidance -January 2004
GHTF/SG3/N99-10:2004 (Edition 2). FINAL DOCUMENT. Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3. Endorsed by: The Global Harmonization Task Force Date: Edition 2 - January 2004. Taisuke Hojo, GHTF Chair The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding Guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use o f this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.
GHTF Study Group 3 - Quality Management Systems Process Validation Guidance– January 2004 Page 5 1 Purpose and scope 1.1 Purpose This process validation guidance is intended to assist manufacturers in understanding quality management system requirements concerning process validation.
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