【摘要】 目的 :实行文件管理保证制剂配制全过程按书面文件规定进行运转 ,减少因口头方式交接而产生差错的危险。方法 :明确文件的定义。分清不同场所和岗位使用的标准管理性和操作性文件类型。提出文件内在质量和管理运转 (设计、制订、修正、审、批、发、归档 )的要求。指正文件编写制订中常见的缺陷。例举标准性文件应涵盖的内容。结果 :制剂配制管理和质量管理的一切活动均以文件的形式来表现 ,使配制和质控全过程的活动以文字为依据。完备的文件管理系统可以避免语言上的差错或误解而造成的事故 ,使每项操作只有一个标准 ,并且留有文字记录可查。真正做到“行有迹 ,查有据 ,追有踪”。结论 :加强文件管理既是实施GPP的需要 ,也是GPP认证的需要 ,更是保证患者用药安全有效的需要。更多还原

【Abstract】 Objective: The purpose of documentary management of preparing is to ensure that the whole preparation procedure shoud be operated by the speifyic document file, and to reduce the possibility of accidence and danger produced through oral transition.Method: Every document shoud be specified. It is necessary to distinguish the different tipe of documents on standard management and opration in different situation and post, to present the documentary request of itself about quality and management, including designing, formulating, modifying, judging, approving, delivering, and filing, to correct frenquent defect in the process of compiling and working out documents, and to list the contents included in the standar document.Result: All the activeties of preparation and quality management shoud be showed by means of documents in order that all its process shoud be based on the written words, and the mistakes or misunderstanding in language might be avoided through the pefect system of documental management so that every operation shoud be operated by only one standard, and may be checked by the record. It is really performed by indication, checked by record, and chased by trace. Conclusion: Enhbancing documentary management is necessary to carry out GPP standard, to be also certificated by GPP standard, and even to ensure the medicines, safe and effective, are used by patient.更多还原