Validation, an essential requirement of Good Manufacture Practice (GMP)
- Author:
Viem Tien Le
- Publication Type:Journal Article
- Keywords:
drug manufacture
- MeSH:
Jurisprudence;
Pharmaceutical Preparations;
Drug Industry
- From:Pharmaceutical Journal
1998;272(12):9-12
- CountryViet Nam
- Language:Vietnamese
-
Abstract:
Validation is an essential requirement of GMP in current World. Requirement of GMP Validation of ASEAN: (1) Validation on manufacturing process. (2) Validation on quantitative method. 3. Validation on equipment. 4. Validation on hygienic standard and hygienic procedures. Results: (1) Guarantee manufacture to have a products, which respond regulated quality. (2) Respond regulated requirement of decree
