Good manufacturing practices : medicinal products for human and veterinary use
著者
書誌事項
Good manufacturing practices : medicinal products for human and veterinary use
（The Rules governing medicinal products in the European Union, v. 4）
Office for Official Publications of the European Communities, 1998
1997 ed
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Eudralex
Pharmaceutical legislation
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内容説明・目次
内容説明
This guide to medicinal products features chapters headed by a principle of GMP, outlining the Quality Assurance objectives of that chapter and a text which aims to provide sufficient detail for manufacturers to be made aware of essential matters to be considered when implementing the principle.
目次
- Directives. Good manufacturing practices. Basic requirements: quality management
- personnnel
- premises and equipment
- documentation
- production
- quality control
- contract manufacture and analysis
- complaints and product recall
- self inspection.
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