路璐数据完整性案例.pdfVIP

数据完整性案例分享 路璐 INTERNAL USE 日程 • 分析问题所在 • 本地药厂实施案例 • 数据完整性控制措施案例 2 分析问题所在 数据完整性问题日益严重 4 案例1：FDA警告信 • During a review of retention samples for Complaint #QC-13-002 regarding missing lot numbers and expiration dates on two product packages of Anascorp® lot (b)(4), the analyst, at the direction of the supervisor, documented that “no missing batch #’s or expiration dates have been located within these samples.” However, your investigation confirmed that there are no retention samples for this lot at your firm. • Instituto Bioclon, S.A. de C.V. 4/16/14 案例2：FDA警告信 • Sterility testing records for Anascorp® Bulk lots (b)(4) and Anascorp® Final Filled lots (b)(4) all show negative results for each day of the (b)(4) day incubation period. However, no analysts work on weekends and plates are only read Monday – Friday. An investigation revealed that microbiology personnel are instructed to record Saturday and Sunday results as negative if Monday’s results are negative as well. • Instituto Bioclon, S.A. de C.V. 4/16/14 案例3：FDA警告信 • Your data integrity consultant should : • 5. Use organizational charts and SOPs to identify the specific managers in place when the inaccurate data reporting was occurring and determine the extent of top and middle management involvement in, or awareness of, data manipulation. 案例4：FDA警告信 “…one of your quality unit employees presented the investigator with a batch record containing his signature, stating that he had performed the review of this batch record. The employee later admitted that he had falsified this CGMP record and stated that he in fact had not performed the review, despite having signed the batch record as the QA reviewer and having released the batch. This data falsification a