APIC清洗验证指导.doc

20140716 ECA新闻：FDA警告信中最常见GMP违规情况?? Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters FDA警告信中最常见GMP违规情况失效调查、供应商确认和稳定性试验不充分 The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient?investigation of unexplained discrepancies and?deviations from?defined standards and specifications in their inspections. The corresponding paragraph?21 CFR 211.192?requires that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments understanding of deviations handling,?failure investigations?and corrective actions is frequently fragmentary. 对2013财年的警告信分析结果显示，最近几年FDA在其检查中，发现对未解释的不符合既定标准和规格的情况及偏差调查不充分。21 CFR 211.192对应的段落要求制药公司说明偏差的原因，采取纠正措施，同时建立完整的文件记录。在过去5年中，每年平均有约22封警告信中列有该缺陷，说明许多公司的质量保证部门对偏差处理、失效调查和纠正措施的理解是不完整的。 Quite interesting is the detailed study of the warning letters referring to GMP violations with regard to 211.192. These warning letters take into account the drugs dosage forms. In particular manufacturers of oral dosage forms were addressees of?warning letters?containing citations with regard to 211.192, followed by parenteral drugs manufacturers, companies in the area of blood/blood products and manufacturers of topical drugs. The respective scenarios are quite different. However, main shortcoming is always the inadequate education and documentation in each incident. 对警告信中与211.192相关的GMP违规情况研究很有意思。从警告信涉及的药品剂型来看，口服剂型生产商首当其冲，其次是注射剂型生产商，以及血液及血液制品和局部用药产品生产商。当然，主要缺点永远都是对每次事件的教育和记录不充分。 A rather unexpected finding in the lineup of the most common GMP violations is the high number of citations with regard to21 CFR 211.84?Testing and approval or rejection of comp