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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。
OBJECTIVE: To implement document management to ensure the preparation of the preparation process according to the provisions of the written documents to reduce the risk of errors due to verbal delivery. Method: Define the definition of the document. Identify the standard management and operational document types used in different locations and positions. Put forward the requirements of internal quality of documents and operation of management (design, formulation, revision, review, approval, issuance and filing). Means the preparation of writing documents common shortcomings. Give examples of what should be covered by the standard document. Results: All the activities of formulation preparation and quality control were presented in the form of documents, which made the preparation and quality control activities based on words. Complete document management system to avoid language errors or misunderstandings caused by the accident, so that each operation is only one standard, and leave a record of the text can be found. Truly “have a trace of the line, check the evidence, follow the track.” Conclusions: Strengthening document management is not only the need of implementing GPP, but also the need of GPP certification. It is also the need of ensuring safe and effective medication for patients.