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Subject: Quality Assurance release requirements и Quality Standard Revision pharm. This batch was tested in confonnance with the approved NDA and complies with Good Manufacturing Practices as outlined in the Code of Federal Regulation, and has not undergone any change of process. Based on the documentation review, this lot meets the Quality Assurance release requirements and there are no outstanding Quality issues associated with this lot.This batch was analyzed against Quality Standard Revision #8. Подкорректируйте, пожалуйста, перевод - Как было показано в ходе проверки документации, данная серия соответствует требованиям по качеству готового продукта, каких-либо вопросов касающихся качества данной серии не было. This batch was analyzed against Quality Standard Revision #8 |
| стандарт качества, пересмотр 8 |
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