FDA 制剂生产厂检查指南Word文档下载推荐.docx

1、Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person（s）.注：此指南是FDA检查官和其工作人员的参考资料。此文件不约束FDA，也不赋予任何人任何权利，特权，利益或豁免权。I. 简介This document is intended to be

2、 a general guide to inspections of drug manufacturers to determine their compliance with the drug CGMPRs. This guide should be used with instructions in the IOM, other drug inspection guides, and compliance programs. A list of the inspection guides is referenced in Chapter 10 of the IOM. Some of the

3、se guides are:该文件旨在为检查药品生产厂家提供一个总体性的指导，以决定他们是否符合药物生产的cGMP法规。该指南应该与IOM（Investigations Operations Manual，即检查操作手册），其他的药品检查指南，及法规符合性程序中的指导一起使用。在IOM的第十章中提供了一个检查指南清单，其中有：o Guide to Inspections of Bulk Pharmaceutical Chemicals.o原料药检查指南o Guide to Inspections of High Purity Water Systems.o高纯水系统检查指南o Guide to

4、 Inspections of Pharmaceutical Quality Control Laboratories.o 药品QC实验室检查指南o Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories.o微生物药品QC实验室检查指南o Guide to Inspections of Lyophilization of Parenterals.o冻干注射剂检查指南o Guide to Inspections of Validation of Cleaning Processes.o

5、清洁验证检查指南o Guide to Inspections of Computerized Systems in Drug Processing.o制药过程中的计算机化系统检查指南o Guideline on General Principles of Process Validation.o工艺验证总体原则指南II. CURRENT GOOD MANUFACTURING PRACTICE REGULATIONSII. CGMPPrescription vs. Non-prescription处方药和非处方药All drugs must be manufactured in accordan

6、ce with the current good manufacturing practice regulations otherwise they are considered to be adulterated within the meaning of the FD&C act, Section 501（a）（2）（B）. Records relating to prescription drugs must be readily available for review in accordance with Sec. 704（a）（1）（B） of the FD&C Act. If t

7、he product is an OTC drug which is covered by an NDA or ANDA, FDA may review, copy and verify the records under Sec. 505（k）（2） of the FD&C Act. However, if the product is an OTC drug for which there is no application filed with FDA, the firm is not legally required to show these records to the inves

8、tigator during an inspection being conducted under Section 704 of the FD&C Act. Nonetheless, all manufacturers of prescription and OTC drugs must comply with the drug CGMPR requirements, including those involving records. The investigator should review these records as part of the inspection in dete

9、rmining the firms compliance with the CGMP regulations. On rare occasions, a firm may refuse to allow review of OTC records stating they are not legally required to. While the firm may be under no legal obligation to permit review of such records, this does not relieve the firm of its statutory requ

10、irement to comply with the good manufacturing practices under section 501（a）（2）（B） of the Food Drug and Cosmetic Act, including the requirements for maintaining records.所有药物的生产过程都必须遵循cGMP原则，否则依据FD&C 法令, 501（a）（2）（B）将认定其为掺假行为。必须提供处方药的记录以便按照FD&C 法令第704（a）（1）（B）进行审核。如果药物是NDA或ANDA范围内的OTC药物，FDA可以根据505（k）

11、（2）进行记录的审核，复制和确认。然而，如果该OTC药物并没有在FDA注册申请，在依据Section 704 of the FD&C 法规进行检查时将不会从法律上要求工厂必须提供给检查官这些记录。尽管如此，所有的处方药和OTC 生产商必须符合cGMP的要求，包括涉及的记录。检察官应当把对记录的审核作为决定生产商是否符合cGMP要求的一部分。偶尔会有公司可能拒绝提供OTC的记录，因为并没有法定要求他们这样做。工厂虽没有法律义务去提供这些记录以供审核，但是这并不减轻工厂仍需符合501（a）（2）（B）cGMP的法定要求，其中包括对记录保持的要求。If a firm refuses review o

12、f OTC records, the investigator should determine by other inspectional means the extent of the firms compliance with CGMPRs. Inspectional observations and findings that CGMPRs are not being followed are to be cited on a List of Inspectional Observations, FDA-483, for both prescription and non-prescr

13、iption drugs.如果一个工厂拒绝审核OTC的记录，检查官应当根据其他检查手段决定该公司对cGMP的符合程度。要把在检查处方药和非处方药时观察到的、发现的不遵循cGMP的地方援引到检查发现列表（即FDA-483）中。Organization and Personnel 21 CFR 211 Subpart B组织和人员The firm must have a quality control department that has the responsibility and authority as described in the referenced CFR. The qualit

14、y control department must maintain its independence from the production department, and its responsibilities must be in writing. Obtain the name, title and individual responsibilities of corporate officers and other key employees as indicated in the IOM.工厂必须有质量控制部门，其职责和权限应与CFR描述的一致。QC部门必须与生产部门保持独立，其

15、职责必须有书面规定。要获取IOM中公司官员和其他关键人员的姓名，头衔和个人职责。In the drug industry, an employees education and training for their position has a significant impact on the production of a quality product. Report whether the firm has a formalized training program, and describe the type of training received. The training received by an employee should be documented.在制药工业，员工的教育背景和岗位培训对于产品的质量有着非常重要的影响。报告工厂是否有正式的培训计划，并描述接受的培训类型。培训应当有文件记录Quality control must do product annual review on each drug manufactured, and have written annual review procedures. Review these reports in detail. This re