Document Controls(cGMP培训系列3).pptxVIP

Records and Reports;General Requirements;General Requirements;Do you also keep records for all components, drug product containers, closures, and labeling? For how long? Where do you keep all these records? Are they readily available? Show me all related records of a batch made on 10/10/2009 (one year ago). ;(b) Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under 211.137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling. (b)全部成份，药品容器、密封件及标签的记录，在有效期满后，保留一年以上。一些无有效期的非处方药品，由于它们符合211?137规定的免除的标准，故从销售最后一批药品计，上述记录保留三年。 ;(c) All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph. (c)本部分要求的全部记录或它们的拷贝，应能随时调出以便授权检查人员复核。这些记录应可以复印或其他方法复制。直接从电子计算机或其它设备中提出的记录，符合本段的要求。 ;(d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available. (d) 本部分要求的记录，可用原始记录或复印件，如光电复印、缩微胶卷和其他可以对文件精确复制的方式。如是缩微方式，应配备适合阅读和复印设备。 ;Do you have an annual review to evaluate quality standards for each drug production? If so, how many batches do you review? How many batches did you review last year? Show me