《WHO-清洁验证新指南--WHO-TRS-1019-53教案资料》由会员分享，可在线阅读，更多相关《WHO-清洁验证新指南--WHO-TRS-1019-53教案资料（7页珍藏版）》请在金锄头文库上搜索。
1、WHO-清洁验证新指南-WHO-TRS-1019-53精品文档WHO 在上个月发布新指南 WHO TRS 1019-53，英文全文303页，本文节选其中 清洁验证部分，进行了翻译，供参考。Appendix3Cleaningvalidation 清洁验证Thetext of this appendix was previously published as:本附录的文本以前以下列形式发表: Appendix 3: Cleaning validation. In: WHO Expert Committee onSpecificationsfor Pharmaceutical Preparation
2、s fortieth report. Geneva: World HealthOrganization; 2006: Annex 4 (WHO Technical ReportSeriesNo. 937; 附录3:清洁验证。在:世界卫生组织药物制剂规范专家委员会第四十次报告。日内瓦世界卫生组织;2006:附件4(世卫组织技术报告系列，第937号;https:/www.who.int/medicines/areas/quality_safety/quality_assurance/SupplementaryGMPValidationTRS937Annex4.pdf?ua=1).1.Princip
3、le 原则1382.Scope 范围1383.General 概述1394.Cleaning validation protocols and reports 清洁验证方案和报告1395.Personnel 人员1426.Equipment 设备1427.Detergents 清洗剂1428.Microbiology 微生物1439.Sampling 取样14310.Analytical methods 分析方法14511.Establishing acceptable limits 确定可接受标准1461.Principle原则1.1The obxxxxjectives of good ma
4、nufacturing practices (GMP) include the prevention of possiblecontamination and cross-contamination of pharmaceutical starting materials andproducts.药品生产质量管理规范(GMP)的目标包括防止可能的污染和药物原料和产品的交叉污染。1.2Pharmaceutical products can be contaminated by a variety of substances such ascontaminants associated with
5、microbes previous products (both activepharmaceutical ingredients APIs and excipient residues) residues of cleaningagents airborne materials such as dust and particulate matterlubricants andancillary material such as disinfectants and decomposition residues from:药品可以被各种物质污染如污染物与微生物有关以前的产品(包括原料药(api)
6、和赋形剂残留)残留的清洁剂空气传播的物料如灰尘和颗粒物。润滑剂和辅助材料如消毒剂、和残留降解产物: product residue breakdown occasioned by for example the use of strongacids and alkalis during the cleaning process;例如，在清洗过程中使用强酸和强碱会导致产品残渣分解 breakdown products of the detergents acids and alkalis that may beused as part of the cleaning process.洗涤剂、酸和
7、碱的分解产物，可作为清洗工艺的一部分。1.3Adequate cleaning procedures play an important role in preventing contaminationand cross-contamination. Validation of cleaning methods provides documentedevidence that an approved cleaning procedure will provide clean equipmentsuitable for its intended use.适当的清洗程序对防止污染和交叉污染具有重要
8、作用。清洗方法的验证提供文件证明，经批准的清洗程序将提供与其预期用途相适应的清洁设备。1.4The obxxxxjective of cleaning validation is to prove that the equipment is consistentlycleaned of product detergent and microbial residues to an acceptable level toprevent possible contamination and cross-contamination.清洁验证的目的是证明设备对产品、洗涤剂和微生物残留物的清洗一致并达到可
9、接受的水平，以防止可能的污染和交叉污染。1.5Cleaning validation is not necessarily required for non-critical cleaning suchas that which takes place between batches of the same product (or differentlots of the same intermediate in a bulk process) or of floors walls theoutside of vessels and following some intermediate st
10、eps.清洁验证对于非关键性的清洗并不一定是必需的，例如批次相同的产品(或散装过程中相同中间体的不同批次)、地板、墙壁、容器外部以及以下一些中间步骤之间的清洗。1.6Cleaning validation should be considered important in multiproduct facilitiesand should be performed among others for equipment sanitization proceduresand garment laundering.清洁验证应被认为在多产品设施中很重要，并应在设备、消毒程序和服装洗涤等方面进行验证。2
11、.Scope 范围2.1These guidelines describe the general aspects of cleaning validation excludingspecialized cleaning or inactivation that may be required for example forremoval of viral or mycoplasmal contaminants in the biological manufacturingindustry.这些指南描述了清洁验证的一般方面，不包括可能需要的特殊清洗或灭活，例如，在生物制造业中去除病毒或支原体污
12、染物。2.2Normally cleaning validation would be applicable for critical cleaning such ascleaning between manufacturing of one product and another of surfaces thatcome into contact with products drug products and APIs.一般情况下，清洁验证适用于关键的清洗，例如在生产一种产品与另一种产品，与产品、药品和原料药接触的表面之间的清洗。3.General 概述3.1There should be
13、written standard operating procedures (SOPs) detailing thecleaning process for equipment and apparatus. The cleaning procedures should bevalidated.应该有书面的标准操作规程(sop)，详细说明设备和仪器的清洗过程。清洗程序应经过验证。3.2The manufacturer should have a cleaning policy and an appropriate procedure forcleaning validation covering
14、:制造商应制定清洗策略和适当的清洁验证程序，包括: surfaces that come into contact with the product;与产品接触的表面; cleaning after product changeover (when one pharmaceutical formulationis being changed for another completely different formulation);产品转换后的清洗(当一种药物配方被另一种完全不同的配方替换时); between batches in campaigns (when the same formu
15、la is being manufacturedover a period of time and on different days);在批次之间的活动(当同一配方是在一段时间内，在不同的日期生产); bracketing products for cleaning validation. (This often arises whereproducts contain substances with similar properties such as solubility or thesame substance in different strengths. An acceptable
16、 strategy is to firstmanufacture the more dilute form not necessarily the lowest dose and then themost concentrated form.用于清洁验证的产品组。(这种情况经常发生在产品中含有具有类似性质(如溶解度)或具有不同强度的相同物质的地方。一种可接受的策略是首先制造含量较低的剂型(不一定是最低剂量)，然后是含量较高的形式。Thereare sometimes “families” of products which differ slightlyas to actives or excipients.);有时产品的“组”在活性物质或赋形剂
