翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(11)

Some inspections include the coverage of the manufacturer of the drug substance. The safety and efficacy of the finished dosage form is largely dependent on the purity and quality of the bulk active drug substance.

Examine the raw data reflecting the analysis of the drug substance including purity tests, charts, etc.

一些检查应包括药品生产企业的检测范围。成品剂型的安全性和有效性很大程度上依赖于活性药物的纯度和质量。检查体现分析药物的原始数据包括纯度试验，图表等。

Check the impurity profiles of the BPC used in the biobatch and clinical production batches to determine if it is the same as that being used to manufacture full scale production batches. Determine if the manufacturer has a program to audit the certificate of analysis of the BPC, and, if so, check the results of these tests. Report findings where there is substantial difference in impurity profiles and other test results.

在生物利用度实验批和临床生产批中检查《英国药物处方书》杂质的大概情况，以确定它是否与在大规模生产时产生的杂质相同。确定如果药品生产企业有一个《英国药物处方书》分析的审核证书，如果是这样，请检查这些测试的结果。报告结果中和其他测试结果有很大差异的杂质。 --------------------------------------------------------------------吴佩迪

Some older compendial methods may not be capable of detecting impurities as necessary to enable the control of the manufacturing process, and newer methods have been developed to test these products.

旧药典不能检测出必要杂质使生产过程得到控制，而新方法已经投入检测这些产品。

Such methods must be validated to ensure that they are adequate for

analytical purposes in the control and validation of the BPC manufacturing process.

这些方法必需经过验证确保适用于控制与验证BPC制造过程的分析目的。 The drug substance manufacturer must have complete knowledge of

the manufacturing process and the potential impurities that may appear in the drug substance.

药品生产商必须具备制造过程及其潜在杂质出现的完整知识。 These impurities cannot be evaluated without a suitable method and one that has been validated.

没有合适的方法和一个已验证的方案，这些杂质无法评估的。 Physical tests such as particle size for raw materials, adhesion tests for patches, and extrusion tests for syringes are essential tests to assure consistent operation of the production and control system and to assure quality and efficacy.

物理试验如原料的粒度，斑块附着力试验，注射器推出试验都是基本的检测，确保产品和控制系统的持续操作，以保证质量和效力。 Some of these tests are filed in applications and others may be established by the protocols used to manufacture the product.

这些试验需编入应用软件，其它的建立协议用于制造产品。 The validation of methods for such tests are as important as the test for chemical attributes.

这些试验的方法验证对化学药品特性的检测是很重要的。 Physical properties tests often require the use of unique equipment and protocols.

物理性能测试通常需要使用独特的设备和方案。

These tests may not be reproducible in other laboratories, therefore, on site evaluation is essential.

这些测试在其它实验室是不能使用的，因此，现场的评估是必要的。 18. IN PROCESS CONTROLS AND SPECIFICATIONS

过程控制和性能规范

Evaluate the test results from in-process tests performed in the production areas or laboratory for conformance with established sampling and testing protocols, analytical methods, and specifications.

从生产车间或者实验室测试的完成来评估试验结果，达到符合已建立的取样和试验方案 ，分析方法，性能规范。

For example, evaluate the tests for weight variation, hardness, and friability. These tests may be performed every fifteen or thirty minutes during tableting or encapsulating procedures.

例如，从重量差异，硬度，易碎性评估试验。 All testing must comply with CGMP's.

所有试验必需遵守《动态药品生产管理规范》。

The drug application may contain some of the in-process testing plan, including methods and specifications.

药品申请包含内部试验计划，包括方法和技术参数。 The inspection must confirm that the in-process tests were done, as described in the plan, and ascertain that the results were within specifications.

检查必须确认进程内试验已经完成,如前面描述的计划,确定结果是在规范。

The laboratory work for the lengthier tests should also be reviewed. 实验室工作较长的测试也应该被审查。

The methods used for in-process testing may differ from those used for release testings.

进程内测试的方法应不同于放行试验。

Usually, whether the methods are the same or different, the specifications may be tighter for the in-process tests.

通常，不管方法相同与否，性能规范必需符合进程内的测试。 A product with a 90.0%-110.0% assay release specification may have a limit of 95.%-105.0% for the in-process blend.

90.0 ％?110.0 ％含量的放行标准产品可能有一个限度的95 ％ ?105.0％的过程中的混合。

Some of the tests done may differ from those done at release. 这些试验方法可能会不同于已经放行的方法。

For example, a firm may perform disintegration testing as an in-process test but dissolution testing as a release test.

例如，一公司证实裂解试验是内进程试验，但是，溶解试验是释放试验。 Expect to see consistent in-process test results within batches and between batches of the same formulation/process (including development or exhibit batches).

期待看到一致的进程内的测试结果在批量和批次之间相同的配方/过程(包括开发或展览批次)

If this is not the case, expect to see scientific data to justify the variation. 如果不是这种情况,期望看到科学数据来证明这个变化。 19. STABILITY 稳定性

A stability-indicating method must be used to test the samples of the batch. 稳定性要求方法必须能用于批次的取样量。

If there is no stability-indicating assay additional assay procedures such as TLC should be used to supplement the general assay method.

如果没有稳定性要求鉴定额外的分析程序如 …… 此处隐藏：3531字，全部文档内容请下载后查看。喜欢就下载吧 ……