Pharmaceutical Quality Control Labs (7/93)
药品质量控制实验室（7/93）
GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY
CONTROL LABORATORIES 药品质量控制实验室检查指南
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：本文件是FDA调查员和其他人员的参考材料。该文件并没绑定FDA，也没授予任何人任何权利、特权或豁免权。 1. INTRODUCTION 1、简介
The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. 药品质量控制实验室在药品生产与控制的过程当中，扮演着极其重要的角色。
A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. CGMP当中，有相当一部分规则是关于质量控制实验室及产品检测的。 Similar concepts apply to bulk drugs. 同样的概念也适用于原辅料。
This inspection guide supplements other inspectional information contained in other agency inspectional guidance documents. 该检查指南补充其他机构信息库中的指导文件。
For example, Compliance Program 7346.832 requiring pre-approval
NDA/ANDA inspections contains general instructions to conduct product specific NDA/ANDA inspection audits to measure compliance with the applications and CGMP requirements.
例如，合则计划7346.832需要预先核准NDA/ANDA检查所包含的一般性指令，并以此来指导、衡量产品的具体NDA/ANDA检查程序是否符合CGMP的要求。
This includes pharmaceutical laboratories used for in-process and finished product testing.
这包括用于生产的制药实验室与终产品的测试。
2. OBJECTIVE 2、目的
The specific objective will be spelled out prior to the inspection. 在检查之前，具体的目标就应该阐述清楚。
The laboratory inspection may be limited to specific issues, or the
inspection may encompass a comprehensive evaluation of the laboratory's compliance with CGMP's.
实验室检查可以仅限于具体问题或者围绕CGMP中实验室应符合的综合评价展开。
As a minimum, each pharmaceutical quality control laboratory should receive a comprehensive GMP evaluation each two years as part of the statutory inspection obligation. 作为最低要求，每个药品质量控制实验室都应执行自己的法定检验义务，即每两年都应该接受一次全面的GMP评估。 In general these inspections may include
-- the specific methodology which will be used to test a new product -- a complete assessment of laboratory's conformance with GMP's -- a specific aspect of laboratory operations 通常这个检查应该包括以下几点： --用于测试一个新产品的特定方法 --实验室是否符合GMP的全面评估 --一种特定的实验室操作
--------------------------------------------------------陈淑贤 3. INSPECTION PREPARATION
FDA Inspection Guides are based on the team inspection approach and our inspection of a laboratory is consistent with this concept. As part of our effort to achieve uniformity and consistency in laboratory inspections, we expect that complex, highly technical and specialized testing equipment, procedures and data manipulations, as well as scientific laboratory
operations will be evaluated by an experienced laboratory analyst with specialized knowledge in such matters.
District management makes the final decision regarding the assignment of personnel to inspections. Nevertheless, we expect investigators, analysts and others to work as teams and to advise management when additional expertise is required to complete a meaningful inspection.
检查人员的委派由地区主管部门确定，然而我们希望，调查人员、分析人员和其他人员能组成—个检查组，并在需要时为了完成—项有意义的检查，可建议主管部门增加有关方面的专家。
Team members participating in a pre-approval inspection must read and be familiar with Compliance Program 7346.832, Pre-Approval
Inspections/Investigations. Relevant sections of the NDA or ANDA should be reviewed prior to the inspection; but if the application is not available from any other source, this review will have to be conducted using the company's copy of the application.
参加新药审批前检查的小组成员必须阅读并熟悉7346·832号文件即审批前检查或调查文件的内容。检查前应当审查新药申请或简略的新药申请的有关部分，如果该申请书不能从别的来源得到，可对由公司提供的副本进行审查。
Team members should meet, if possible, prior to the inspection to discuss the approach to the inspection, to define the roles of the team members, and to establish goals for completion of the assignment. Responsibilities for development of all reports should also be established prior to the inspection. This includes the preparation of the FDA 483.
如果可能的话，小组成员在检查之前就应当集中，以讨论检查方法，明确每位组员的角色，并确定目标以完成委派的任务。检查前还要确定负责起草各报告，包括准备FDA483文件的责任。
The Center for Drug Evaluation and Research (CDER) may have issued deficiency letters listing problems that the sponsor must correct prior to the approval of NDA/ANDA's and supplements. The inspection team is expected to review such letters on file at the district office, and they are expected to ask the plant for access to such letters. The team should
evaluate the replies to these letters to assure that the data are accurate and authentic. Complete the inspection even though there has been no response to these letters or when the response is judged inadequate.
药品评价和研究中心(CDER)可能已经发出有关缺陷信件，列举出存在的各种问题。要求受检企业必须在新药申请或简略的新药申请和补充文件被批准前予以改正。希望检查组审查这些已经在FDA地区办公室归档的信件，并向药厂要求了解这些信件的内容。检查组还要评价药厂对这些信件的答复，以确保数据的准确和真实。即使药厂没有对这些信件作出答复，或者认为药厂的答复不充分，也应当完成这项检查工作。
4. INSPECTION APPROACH 检查方法 A. General 总则
In addition to the general approach utilized in a drug CGMP inspection, the inspection of a laboratory requires the use of observations of the laboratory in operation and of the raw laboratory data to evaluate compliance with CGMP's and to specifically carry out the commitments in an application or DMF. When conducting a comprehensive inspection of a laboratory, all aspects of the laboratory operations will be evaluated.
除了采用对药品进行现行药品生产质量管理规范的—般检查方法之外，对实验室的检查还要采用察实验操作和检查原始数据的方法，以评价其符合现行药品生产质量管理规范的情况，以及实现申请书中或者药品工艺档案中约定的义务。对实验室进行综合检查时，应评价实验室操作的
各个方面。
Laboratory records and logs represent a vital source of information that allows a complete overview of the technical ability of the staff and of overall quality control procedures. SOPs should be complete and adequate and the operations of the laboratories should conform to the written
procedures. Specifications and analytical procedures should be suitable and, as applicable, in conformance with application commitments and compendial requirements.
实验室记录和实验记录本是不可缺少的资料来源，从这些资料中可以全面了解从业人员的技术能力和全部质量控制程序。标准操作程序应当是全面而恰当的，实验室的操作应当与书面的规程相—致。规格标准和分析程序应当合适，而且也符合申请中记载的内容及法定方法的要求。 Evaluate raw laboratory data, laboratory procedures and methods,
laboratory equipment,including maintenance and calibration, and methods validation data to determine the overall quality of the laboratory operation and the ability to comply with CGMP regulations.
要评价原始实验数据、实验程序和方法、实验室设备，包括设备的维护和校正，以及实验方法的验证数据，以确定实验室操作的总体质量和符合现行药品生产质量管理规范的能力。
---------------------------------------------------------------------谢艳红 Evaluate raw laboratory data, laboratory procedures and methods,
laboratory equipment,including maintenance and calibration, and methods validation data to determine the overall quality of the laboratory operation and the ability to comply with CGMP regulations.
评估的原始实验室数据，实验程序和方法，实验室设备，包括维护和校准以及分析方法验证数据，来确定实验室操作的能力综合质量是否有能力适合CGMP法规。
Examine chromatograms and spectra for evidence of impurities, poor technique, or lack of instrument calibration.