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天津康森生物科技有限公司 (天津市西青区赛达三支路33号)
检查日期: 2015年8月3至5日
违规项:
1.Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).贵公司没有放行前有适当实验室测定每批药品，保证其符合药品的最终质量标准，包括属性和活性成份的含量
2.Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).贵公司没有在未经质量部门放行前保留每批成份、药品容器和密封直到该批次已适当被取样、测试或检查。
3.Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).贵公司没有建立和遵循药品稳定性的书面试验方案和使用这稳定性测试的结果来确定适当的贮存条件和有效期。
4.Your firm failed to establish written procedures for production and process controls, including validation protocols and reports, designed to assure that your firm’s drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).贵公司没有建立生产和工艺控制的书面程序，包括验证方案和报告，旨在确保贵公司的药品有声称的鉴别、含量、质量及纯度。
5.Your firm failed to establish and follow written procedures for cleaning and maintenance of equipment used in the manufacturing, processing, packaging or holding of a drug product (21 CFR 211.67(b)).贵公司没有建立和遵循使用在生产包装和储存药品的清洁和设备维护书面程序。
In your response of August 5, 2015, you acknowledged the significance of the CGMP observations and said "You did not commit to any corrective actions regarding the CGMP violations observed on the inspection".在2015年8月5日的回复，贵公司确认了CGMP观察的重要性以及说 “你没有对于检查中发现的CGMP违规承诺任何的纠正措施" 。
 
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