Zdrowie i gospodarka · 7/16/1998
Medical Devices: Draft Global Harmonization Task Force Study Group 3 Process Validation Guidance; Draft; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Global Harmonization Task Force Study Group 3 Process Validation Guidance.'' The draft guidance document has been created by members of the International Global Harmonization Task Force Study Group 3 (GHTF SG3) to propose harmonized international process validation technical requirements and guidance for the manufacture of medical devices. The agency is requesting public comment regarding the draft guidance document as proposed by the GHTF SG3. Because FDA intends to utilize the GHTF document as guidance for the agency and industry, FDA is also publishing this document for comment under its good guidance practices (GGP's).