PICS验证指南(中英文)

2. INTRODUCTIONThe basic principles and application of qualification and validation are describedin Annex 15 to the PIC/S and EU Guide to GMP.This document comprises individual Recommendations on four topics relatingto Equipment Qualification and Process Validation in pharmaceuticalmanufacture, as follows:Ø Validation Master PlanØ Installation and Operational QualificationØ Non-Sterile Process ValidationØ Cleaning ValidationThe four Recommendations comprising this document define general principles pertaining to each of the topics.2. 导言PIC/S和EU GMP指导原则的附录15中对确认(Qualification)和验证(Validation)的基本原则及应用进行了阐述。

本文件包含了药物生产过中与设备确认和工艺验证相关的如下这四个方面的建议：验证主计划安装和运行确认非无菌工艺验证清洗验证本文件中的建议确定了上述这四个方面的基本原则。

2.1 Purpose of the document2.1.1 The topics of these Recommendation documents reflect some of the areas in pharmaceutical manufacture identified by both Inspectorates and thePharmaceutical Industry as requiring guidance additional to that given in thecurrent PIC/S GMP Guide.2.1.2 The purpose of this document is to provide guidance for GMP inspectors in reviewing the issues covered to use for training purposes and in preparation for inspections.2.1 本文件的目的2.1.1 这些建议性文件的主题涉及的是那些审计人员和制药企业都认为需要对现行PIC/S GMP指导原则进行补充的领域。

2.1.2 本文件的目的在于给GMP审计人员提供一个指导文件，可用于培训和检查的准备工作。

2.2 Scope of the document2.2.1 It is considered that the principles defined in the individual Recommendation documents can be applied equally in the manufacture of active pharmaceutical ingredients (APIs) and finished pharmaceuticals.2.2.2 At the time of issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence.2.2.3 The advice in these Recommendations is not mandatory for industry. However, industry should consider these Recommendations as appropriate.2.2.4 It should be noted that additional requirements not contained in these Recommendations pertain to computer systems impacting GMP.2.2 范围2.2.1 每个建议文件中所确定的原则既适用于原料药，也适用于制剂。

2.2.2 在公布时，本文件反映了当前的技术水平。

但并不能因此而成为技术革新和追求卓越的一种障碍。

2.2.3 本文件中的建议并不强制制药企业执行。

然而，制药企业应当要适当考虑这些建议。

2.2.4 需要注意的是本文件并未包括会影响GMP的计算机系统方面的附加要求。

2.3 Aims of Qualification and ValidationThe qualification and validation process should establish and providedocumentary evidence that:2.3.1 The premises, the supporting utilities, the equipment and the processes havebeen designed in accordance with the requirements of GMP. This normallyconstitutes Design Qualification or DQ.2.3.2 The premises, supporting utilities and the equipment have been built andinstalled in compliance with their design specifications. This constitutesInstallation Qualification or IQ.2.3.3 The premises, supporting utilities and the equipment operate in accordancewith their design specifications. This constitutes Operational Qualification orOQ.2.3.4 A specific process will consistently produce a product meeting itspredetermined specifications and quality attributes. This constitutes ProcessValidation or PV. The term Performance Qualification or PQ may be usedalso.2.3 确认和验证的目的确认和验证的目的在于建立和提供如下这些方面的书面证据：2.3.1 厂房，设施，设备和工艺是根据GMP要求进行设计的。

这通常就是设计确认(DQ, Design Qualification).2.3.2 厂房，设施和设备是根据设计要求进行建造和安装的。

这就是安装确认(IQ, Installati on Qualification).2.3.3 厂房，设施和设备的运行符合其设计要求。

这就是运行确认(OQ, Operational Qualifi cation).2.3.4 一特定工艺能够持续地生产出符合预期质量标准和质量属性的产品。

这就是工艺验证(PV, Process Validation)。

也被称为性能确认(PQ, Performance Qualification)2.4 Terminology2.4.1 Terminology used in the four Recommendation documents which is not definedin the current glossary of the PIC/S Guide to GMP, is presented at the end of this document.2.4.2 It is worth commenting on the interchangeability of terms typically accepted internationally. The term ‘validation’ is often assumed to encompass theelements of equipment qualification, both Installation Qualification andOperational Qualification, in addition to validation of the process itself. However,for the purpose of these Recommendations, terms are not usedinterchangeably.2.4 术语2.4.1 本文件中所用到的术语，若现行PIC/S GMP 指导文件中没有对其进行解释，则在本文件的结尾处会有其解释。

2.4.2 有必要对术语的可替换性进行说明，特别是那些国际认可的术语。

“验证(Validation)”通常被认为除了验证工艺本身外，也包括设备确认(equipment qualification)的安装确认和运行确证。

然而，在本文件中，这些术语是不能互换的。

2.5 When to qualify and validate?2.5.1 Any aspect of, including significant changes to, the premises, the facilities, the equipment or the processes, which may affect the quality of the product, directlyor indirectly, should be qualified and validated.2.5.2 The concept of equipment qualification is not a new one. Many suppliers have always performed equipment checks to confirm function ality of their equipmentto defined specifications, both prior to and after installation.2.5.3 Similarly, development, scale-up and transfer into production of products and processes is not a new concept. Terminology may change and even differbetween users, but the basic concepts of validation are immutable.2.5.4 However, documented records of qualification and validation work in general, have sometimes not been given sufficient consideration by either equipmentsuppliers or pharmaceutical companies in the past. As a consequence,companies have not always been able to provide documented evidence toinspectors reflecting the time and effort spent in carrying out these activities.2.5 何时进行确认和验证2.5.1 厂房，设施，设备或工艺的可能会直接或间接影响到产品质量的方方面面及其重大变更都应当要进行确认和验证。