翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(2)

检查色谱和光谱杂质的证据，技术差，或缺乏仪器的校准。

Most manufacturers use systems that provide for the investigation of laboratory test failures. These are generally recorded in some type of log. Ask to see results of analyses for lots of product that have failed to meet specifications and review the analysis of lots that have been retested,

rejected, or reworked. Evaluate the decision to release lots of product when the laboratory results indicate that the lot failed to meet specifications and determine who released them.

大多数厂家使用系统为实验室测试失败调查提供调查。要求查看不符合规定批产品的已经复验的分析结果，审查分析已重新测试，拒绝，或返工。当实验室检查结果不符合规定时评价是否放行产品以及决定由谁放行。

B. Pre-Approval预审批

Documents relating to the formulation of the product, synthesis of the bulk drug substance, product specifications, analysis of the product, and others are examined during the review process in headquarters. However, these reviews and evaluations depend on accurate and authentic data that truly represents the product.

有关产品配方的文件，合成原料药，产品规格，产品分析，和其他人审查，以及其他的相关文件进行检查。然而，这些审查和评价取决于真正能代表产品准确和可靠数据。

Pre-approval inspections are designed to determine if the data submitted in an application are authentic and accurate and if the procedures listed in the application were actually used to produce the data contained in the application. Additionally, they are designed to confirm that plants (including the quality control laboratory) are in compliance with CGMP regulations.

批准前检查的目的是确定提交申请的数据是否是真实、准确的，以及在申请中列出来的规程是否实际用于生产应用程序中包含的数据。此外，他们的目的是确认工厂（包括质量控制实验室）是在遵守CGMP要求。