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本帖最后由 JOO 于 2020-11-24 09:58 编辑
一、交换文件。
如题，下图是缺少的文件，希望和蒲友们交换（最新换到了PDA TR84 数据完整性），只要现行版哦，最好是可搜索版本啦，扫描件不太方便呢。
ISPE列表
图1：ISPE列表（发布日期即现行版日期，列表中的我都没有）
PDA列表
图2：PDA列表（红字标明了缺少的是英文版还是中文版，还是都没有= =！）
其他未列出的我应该都有（除了生物药相关的，我司不涉及没有收集），但不一定是正版哦。
二、翻译交流
最近在翻译PDA TR79 DIP检查，不专业，希望大家指正。
1.0 Introduction
Detection of foreign particulates and other defects in transparent parenteral solutions filled into clear containers is challenging under the best conditions, but is virtually impossible with opaque formulations and/or container types. Product/container combinations that obscure particulates are commonly known as “difficult-to-inspect” parenterals. 若能寻找到最佳条件，检查装入透明容器的透明非经胃肠道溶液中的异物和其他缺陷，这是一种挑战。但对于非透明制剂或/和容器类型，这实际上是不可能实现的。这类对异物具有遮盖性的产品/容器的组合通常被称为“难以检查”的非经胃肠道药物。 In spite of the challenges, regulators around the world expect 100% unit inspection. These requirements are laid out primarily in the pharmacopeias: the United States (USP), European (Ph. Eur.), Japanese (JP), and other world pharmacopeias have outlined inspection conditions and expectations that require manufacturers to examine 100% of all parenteral units for visible foreign particulates, including difficult-to-inspect parenteral (DIP) products. The World Health Organization (WHO) has a regulation for it, as well. 尽管面对挑战，世界各地的监管机构仍希望进行100%的单元检查。这些要求基本在药典中提出：美国（USP），欧洲（Ph.Eur），日本（JP）和其他世界性的药典列举出了检查条件和期望，要求制造商对100%的产品进行可见异物检查，包括难以检查的非经胃肠道（DIP）产品。世界卫生组织WHO也对此做出了规定。 Any finished product unit that exhibits visibly detectable particulates during a qualified inspection must be rejected from the batch before it is released to distribution. USP General Chapter <790> Visible particulates in injections is a unique standard, because it defines the term “essentially free” of foreign particulate matter following the mandatory 100% in-process inspection and calls for a statistically-derived, acceptable quality limit-based inspection at the time of batch release (1). Other major pharmacopeias use slightly different, but equivalent terms. Ph. Eur. uses “practically-free” and JP uses “free from readily visible,” yet neither of these mentions a final acceptable quality limit (AQL) inspection (2,3). Alternate statistically based attribute sampling plans, such as rejectable quality level (RQL), may be employed if they are shown to be equivalent or better than the AQL as a defect control process. Additionally, USP General Chapter <1> Injections and implanted drug products (parenterals)—product quality tests and USP <790> are currently the only pharmacopeial standards that also require a supplemental destructive inspection or testing for difficult-to-inspect parenteral products (1,4). 在产品放行允许分销前，任何在有效的检查中被明显检测出异物的成品必须先从批次中剔除。USP凡例<790>注射剂中的可见颗粒是标准中的一个特例，因为它定义了强制性100%在线检查中“基本上不含”异物的含义，并且要求在批次放行时，从统计角度出发，进行可接受的基于质量限制的检查（1）。其他药典使用的术语略有不同，但在定义上都相差无几。EP使用“几乎不含”，而JP使用“难以可见”，但两者都未提及一个最终可接受的质量限制（AQL）检查（2，3）。在缺陷控制过程中，如果备用的基于统计的属性抽样计划的表现与AQL相当或优于AQL，如不合格质量水平，将会被采用。此外，USP凡例<1>注射剂与植入药品（非经胃肠道）-产品质量测试和USP<790>是目前唯一要求对难以检查的非经胃肠道药品进行补充破坏性检查的药典标准（1，4）。 In-process manufacturing inspection has been designed to ensure that the quality of the batch is maintained by detecting and removing defective units. However, many difficult-to-inspect parenteral dosage forms diminish the ability to detect common defects such as visible intrinsic or extrinsic foreign particulate matter using 100% in-process inspection that controls residual defects. Difficult-to-inspect parenteral dosage forms include opaque and deeply colored solutions, lyophilized cakes, powders, concentrated suspensions, and emulsions. Difficult-to-inspect parenteral container types might include plastic syringes, blow-fill-seal packaging, flexible bags, specialty containers, and medical devices. These types of products require some form of supplemental analysis or destructive inspection or testing and monitoring as part of the control strategy to ensure a product meets not only the USP <790> definition of “essentially free from visible particles,” but also the harmonized subvisible particle acceptance guidance outlined in major world pharmacopeias (4). To accomplish this, a lifecycle-based particulate and physical defect management approach, along with a destructive inspection and trending strategy, are essential for detecting, identifying, and preventing foreign particulates in parenterals. It should be stressed that without robust controls over each element of the up-stream supply chain, as well as all of the manufacturing steps leading to the finished dosage form, the DIP product may not result in adequate particulate defect removal equivalent to a clear solution in a similar container system that can be readily visually inspected. Emphasis should be placed on the effectiveness to reduce impact to product quality and patient risk which is best achieved at the earliest points in the lifecycle process. 设计出的在线生产检查是为了通过检测和去除缺陷项来确保批次质量的均一稳定性。但是，对于许多难以检查的非经胃肠道剂型，常见缺陷被检测可能性都被降低了，例如使用在线100%控制残留缺陷的检查来检测可见的内在或外在异物。DIP剂型包括不透明和深色的溶液、冻干剂型，粉剂，浓缩混悬剂和乳剂。DIP容器类型可能包括塑料注射剂，吹灌封包装，集装袋，专用容器和医疗器械。这类型的产品需要某种形式上的补充分析或破坏性检查以及监控，以此作为控制策略的一部分以确保产品不仅符合USP<790>的“基本上不含可见颗粒”的定义，而且还符合主要世界药典中统一概述的不溶性微粒接受指南（4）。为此，一个基于生命周期的微粒和物理缺陷，并伴有破坏性检查和趋势的策略的管理办法，对于非经胃肠道异物的检测、识别和预防至关重要。值得强调的是，如果不严格控制上游供应链中的每个要素，以及影响最终剂型的所有生产步骤，那么与可进行目视检查的清澈溶液相比，即使拥有类似的容器系统，DIP产品可能无法实现等效的颗粒缺陷剔除效果。应重点着眼于降低对产品质量和患者风险的影响的有效性上，这是在生命周期过程中最早实现的。 When beginning an initial destructive testing process, some difficult-to-inspect parenteral products might not immediately meet the expectations stated in USP <790>. In all cases, process monitoring data and historical trending is required to evaluate and optimize appropriate process control levels for both visible and subvisible particulates. Short- to long-term action plans may be necessary to update the supporting upstream lifecycle controls for facilities, raw materials, components, product contact equipment, maintenance cycles and inspection or testing procedures in order to meet current regulatory expectations and good manufacturing practices. 开始首次破坏性测试时，某些DPI产品可能难以立刻达到USP<790>中所述的期望。所有情形下，都需要工艺监控数据和历史趋势来评估和优化适当的可见颗粒和不溶性微粒控制水平。为了满足当前的法规要求和良好生产规范，可能需要短期或长期的行动计划来更新对设施、原材料、组件、与产品接触的设备、维保周期以及检查或测试程序的上游生命周期辅助控制。 1.1 Purpose 目的This technical report describes best practices for difficult-to-inspect parenteral product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General Chapter <1790> Visual inspection of injections (5). USP provides some guidance on acceptance criteria based on a statistical sampling plan designed for destructive testing. 本技术报告介绍了难以检查的非经胃肠道产品的生命周期管理、破坏性测试的最佳实践，以及补充USP凡例<1700>注射剂目视检查中给出的指南的部分内容（5）。根据为破坏性测试设计的统计学抽样计划，USP就验收标准提供了一些指导。 In 2015, the PDA Task Force on Particulate Matter Control in Difficult-to-inspect Parenterals initiated an industry survey on opaque or difficult-to-inspect parenteral products that established current particle testing practices, and statistical sampling for both APIs and finished products (6). The survey, literature and pharmacopeial references along with the collective expertise of Task Force contributors form the basis for the information provided in this technical report. 2015年，PDA难以检查的非经胃肠道制剂控制特别工作组这对不透明或DIP产品发起了一项行业调查，该调查建立了当前的颗粒测试实践，和API和成品的统计抽样（6）。调查、文献和药典引文以及工作队贡献者的专业知识共同构成了本技术报告信息提供的基础。
1.2 Scope 范围Although the current USP guidance does not completely address difficult-to-inspect parenteral products, this technical report is intended to provide logical pathways to DIP inspection and testing to support continual process improvement in the industry. 尽管现行的USP指南尚未完全解决DIP产品，本技术报告旨在提供DIP检查和测试的逻辑途径，以支持行业持续的工艺改进。 Critical physical container defects (cracks or seal integrity) that could compromise sterility should also be removed by a 100% non-destructive inspection. Neither this physical container/closure defect inspection nor enhancements or modifications of specific inspection conditions are within the scope of this report. 可能损害无菌性的物理容器的重大缺陷（裂纹或密封完整性）也应通过100%无损检查来消除。本报告不涉及针对此物理容器/密闭器的缺陷检查，或特定检查条件的提高或调整。
3.0 Overview Difficult-to-inspect parenteral (DIP) dosage forms have a diminished capability for 100% visual inspection of particulate matter due to the container system, the formulation, or both. USP <1> and USP <790> call for a supplemental destructive inspection when the parenteral product is not capable of a full 100% inspection for particulate matter in the marketed state. This guidance has been included in USP <1> since 2006 and, more recently, has been added to USP <790>, which was adopted in August 2014 (1,4). 由于容器系统，制剂本身或两者兼而有之，DIP剂型无法完全进行100%目视检查颗粒物。当市场上的非经胃肠道产品无法完全进行100%检查颗粒物时，USP<1>和<790>要求进行补充破坏性检查。该指南自2006年就被纳入USP<1>中，最近又与2014年8月被纳入USP<790> （1，4）。 The pharmaceutical industry manufactures sterile, stable, pure, efficacious, and potent products in many forms. All injectable products should meet equivalent compendial guidelines for quality attributes, regardless of form, presentation, cost, or shelf-life. Difficult-to-inspect products are subject to the same compendial standards as other, easier to inspect forms. Therefore, where 100% inspection is not fully effective in removing visually detectable particulate matter, companies should put in place a robust lifecycle approach and utilize the appropriate statistical destructive inspection or testing to control and assess each batch of product released for distribution. Certain biotechnology products (e.g., therapeutic proteins, cell therapy, etc.) may also be categorized as DIP products. They may exhibit a very cloudy appearance or display inherent particle agglomerates in the visible range that can interfere with the detectability of foreign particulate matter. 制药行业生产多种剂型的无菌的、稳定的、单一的、有作用的和有效的产品。所有的注射产品均应符合相应的药典指南，以保证其质量属性，无论是剂型、外观、成本或保质期。难以检查的产品和其他易于检查的剂型受同样的法规标准约束。因此，当100%检查无法完全有效剔除视觉上可见的颗粒物时，公司应采用可靠的生命周期方法，并利用适当的统计破坏性检查或测试来控制和评估每批放行发运的产品。某些生物技术产品（如蛋白质制剂，细胞疗法等）也可以归为DIP产品。它们可能会表现出非常浑浊的外观，或者在可见光范围内呈现出固有的颗粒团聚，这会干扰异物颗粒的可检测性。 The standard acceptable quality limit (AQL) inspection of DIP products focuses on as-marketed appearance and physical container/closure defects, along with readily visible particulate detection. The 100% manual, semiautomated, or automated inspection of product is, by design, intended to remove individual units exhibiting unwanted visible particulate or physical defects. This is relatively straightforward for clear solutions in transparent containers; however, visible particulate matter can remain in each batch of DIP product in the marketed form despite having undergone the 100% in-process inspection. Therefore, a supplemental, statistically-based reconstitution or other destructive test is needed as a quality check for each batch to determine how frequently and what types of intrinsic/extrinsic foreign particulates are present. This information must be recorded and historically trended to determine control limits and process capability. When developing acceptance testing for DIP products the intended patient populations, and route of administration for the product should be considered. DIP产品的标准可接受的质量限制检查着重于市售外观和物理容器/密闭器缺陷，以及可观察的颗粒物检查。按照设计，100%人工、半自动或全自动检查的目的是剔除那些表现出有害的可见颗粒或物理缺陷的单个单元。对于透明容器清澈液体，检查相对简单。但是，尽管进行了100%在线检查，可见颗粒物仍会存在于市售包装的每批DIP产品中。因此，需要进行基于统计的补充重查或其他破坏性检查，作为对每批产品的质量检查，以确定内源/外源异物颗粒出现的频率和类型。必须记录此信息并进行历史趋势回顾以确定控制限度和检查能力。为DIP产品建立验收测试时，应考虑目标患者人群和产品的给药途径。 3.1 PDA Survey on DIP Products 关于DIP产品的PDA调查The PDA Survey: 2015 Particulate Matter in Difficult-to-inspect Parenterals collected general benchmark information from 101 companies worldwide on particulate matter inspection and testing in DIP products (6). Only about 50% of the responding companies producing DIP products currently comply with the guidance in USP <1> and USP <790> for supplemental destructive testing. PDA调查：2015年难以检查的非经胃肠道制剂的颗粒物一书收集了全球101加公司有关DIP产品的颗粒物检查/测试的一般基准信息（6）。受访公司中，目前只有约50%按照USP<1>和<790>中的补充破坏性测试进行DIP产品生产。 Other key results are listed below. 其他关键结果在下文列出。 Note: Some survey results may not add up to 100 percent as responding companies may have multiple product types and or multiple manufacturing sites. Utilize the percentages listed as a relative trend indicator, therefore the higher the percentage the larger number of positive responses that were received. 注意：由于受访公司可能拥有多个产品类型和/或多个生产地点，某些调查结果可能没有达到100%。使用列出的百分比作为相对趋势指标，百分比越高，收到的积极响应数越大。 Demographics 人口统计• Asia-Pacific (17%) 亚太地区 • Europe (42%) 欧洲地区 • North America (39%) 北美地区 • South America (3%) 南美地区 Container Types 容器类型• Most reported products are packaged in clear glass vials or syringes (85%). • 大多数报告的产品包装在透明玻璃小瓶或注射器中（85%） • Other common DIP container types are amber glass (29%) and plastic syringes (17%). • 其他DIP容器则为棕色玻璃瓶（29%）或塑料注射器（17%） Formulations 剂型• DIP formulation types manufactured were predominantly lyophilized (93%), followed by suspensions (51%) and opalescent to milky solutions (29%); all other formulation types comprised <20% of total production. • DIP制剂类型主要为冻干剂（93%），悬浮剂（51%）和乳白色或乳状溶液（29%），其他的剂型累计不到总数的20%。 Inspection and Testing 检查和测试• All responding companies are currently performing as marketed, nondestructive, 100% inspection; most follow this with a nondestructive AQL inspection. • 目前，所有受访公司都按照现执行的非破坏性100%检查；大部分会再进行非破坏性AQL检查。 • Questions on destructive testing focused on the inspection or testing methods and various sampling plans and limits that applied. Currently the predominant methods that are being used are reconstitution and visual inspection of solid (lyophilized and powder) product or membrane filtration/microscopic examination. • 关于破坏性测试的问题集中于检查或测试方法以及适用的各种采样计划和限度。当前，主要使用的方法是用于固体制剂（冻干剂和粉剂）的重构法和目视法，或滤膜过滤法/显微镜检查法。 • One significant survey finding was that only half of the DIP product manufacturers are conducting supplemental destructive testing as directed by USP <1> and USP <790> which indicates a significant lack of compliance to the USP requirements. • 一项重要的调查发现只有一半的DIP产品制造商按照USP<1>和<790>的指示进行补充破坏性测试，这表明对USP要求的遵循严重缺乏。 Criticality of Foreign Particulate Matter 异物颗粒物的严重性• Currently USP <790> calls for an AQL limit for particles that is clearly in the major defect category. The percentage of firms that reported classifying particles in DIP products as “critical” defects was 72%; that appears high compared to the 59% reported in the PDA Survey: 2014 PDA Visual Inspection of all parenteral products (9). This elevated number of firms using the term critical for particles in DIP products may potentially be misleading. During this specific survey these responses could be based on the fact that the background visible particles during nondestructive visual inspection cannot be detected due to the product formula or container system. In other words, if you can’t detect the particles your trending would provide very low calculated action levels at or near zero (critical). Logically this does not reflect the true particle burden of the DIP product or the appropriate classification of a major particle defect found during destructive testing. • 目前，USP<790>要求对明显属于主要缺陷项的颗粒设置AQL限度。报告中，将DIP产品颗粒归类为“严重”缺陷项的公司百分比为72%；与PDA调查：2014年所有非经胃肠道产品的目视检查中呈现的59%相比，这一数据显得较高（9）。使用“严重”术语的DIP产品制造公司数量上升这一现象可能会产生误导。在此特定调查期间，这些回复可能是基于以下事实：由于产品配方或容器系统，在非破坏性检查过程中，背景可见颗粒物无法被检测到。换言之，如果无法检查到粒子，则据趋势得到的行动限将非常低，处于或接近与零（严重缺陷项）。从逻辑上讲，这并不能反应DIP产品的真实颗粒负荷或在破坏性测试中可发现的主要颗粒缺陷的合适分类。 • The response to those questions indicated that only 29% were using either an AQL of ≤0.1%, or an “accept on zero” approach in DIP products, which is probably a more accurate reflection of the use of the “critical” defect category in destructive testing. • 这些问题的回复表明，对于DIP产品，只有29%的公司采用AQL ≤0.1%或“零限度”的方法，这样可能更准确地反映出破坏性测试中“严重”缺陷分类。 • An equal number of respondents (29%) indicated the use of an AQL in the range of 0.25% to 0.65%, which is more often associated with a “major” defect category as currently specified in USP <790>. • 相同比例（29%）的受访对象表示使用的AQL在0.25%至0.65%范围内，这通常与现行USP<790>中规定的“严重”缺陷类别有关。 • Approximately 10% reported using an AQL ranging from 1.5% to 4.0%, a value greater than the compendial AQL of ≤0.65% that was founded on clear containers and transparent formulations. • 根据调查报告，约有10%的受访者使用的AQL在1.5%至4.0%的范围内，这大于透明容器和透明制剂的法定AQL ≤0.65%。 Supplemental Inspection or Testing 补充检查或测试• Many firms (52%) do not currently comply with the requirement to conduct supplemental destructive testing on DIP products as described in USP <790> and <1> (1,4). This may be due, in part, to the geographic distribution of the respondents that do not distribute product in the United States. • 许多公司（52%）目前未遵循USP<790>和<1>中对DIP产品进行补充破坏测试的要求（1，4），这有可能是受访对象的地理分布所致，这些公司并不在美国分销产品。 • Those that do conduct destructive testing responded that they most often use ANSI/ASQ Z1.4 or ISO 2859 S-1 (13%) and S-2 (13%) sampling plans to determine the sample size (10,11). • 进行破坏性测试的受访者表示，NSI/ASQ Z1.4 或 ISO 2859 S-1 （13%） 和S-2（13%）抽样计划经常被使用以确定样本量（10，11）。 • Fixed sample sizes of 10-20 units (10%) are also used. • 10%的受访这表示，还会使用10-20个单位作为固定样本大小。
Methods of Destructive Testing 破坏性测试的方法• Reconstitution and inspection of Lyophilized and Powder forms • 适用于冻干剂和粉剂的重组检查法 • Membrane filtration or sieving for a variety of product formulation types • 适用于多种剂型的膜过滤法或筛分法 • Clarification by adding a solvent, acid, or base for suspensions and emulsions • 对于悬浮剂和乳剂，可通过添加溶剂、酸或碱使其变澄清 • Transfer to a clear container and inspection (may significantly increase the chance of lab contamination) • 转移至透明容器中并进行检查（有可能大大提升污染实验室的几率） Particulate Matter Characterization or Identification 颗粒物的鉴别或辨别• Of the firms responding, 50% have on-site Level 1 (in situ) or Level 2 (microscopic) particulate characterization capabilities, which indicates that a significant portion of parenteral manufacturers (~50%) may not have real-time or timely capability to react to particle issues on-site. • 在回复的受访公司中，50%现场具有1级（原位）或2级（微观）粒子鉴别功能，这表明很大一部分的非经胃肠道产品制造商（约50%）可能没有实时或及时的应对现场颗粒问题的能力。 • Use of external or contract services for particulate characterization is increasing (42%). • 颗粒鉴别外包或合同服务被越来越多地使用（42%）。 • Some firms (9%) do not perform any particulate characterization on their products. • 一些公司（9%）未对其产品进行任何颗粒鉴别。 • Analytical support functions, such as particulate ID by Level 3 imaging and elemental composition by scanning electron microscopy with energy dispersive x-ray SEM-EDX for inorganic materials or molecular characteristics by FTIR or Raman spectroscopy for organic materials, in many instances also are not performed in-house (62%). This may be due to the expense of spectroscopy equipment. • 许多情况下（62%），内控中也并不采用分析支持功能，比如通过3级成像获得颗粒ID，通过使用能量色散X射线SEM-EDX原来的扫描电子显微镜获得无机材料的元素组成，通过FTIR或拉曼光谱对有机材料的分子特性进行分析。这可能是由于光谱设备的成本。 • Sixty-three percent (63%) of respondents have developed a particulate library for finished product: 16% for APIs, 10% for excipients, and 32% for primary packaging components. • 63%的的受访者为成品开发了颗粒物库：针对API的比例为16%，辅料的比例为10%，外包组件的比列为32%。 Patient Risk 患者风险• The survey shows that a range of factors are considered when assessing patient risk when particles are present, including clinical relevance/health risk (75%), particle type/size (71%), route of ad- ministration (49%), and historical process capability (44%). • 调查显示，当存在颗粒物时，评估患者风险时应考虑一系列因素，包括临床相关性/健康风险（75%），颗粒类型/大小（71%），给药途径（49%），和既往工艺能力（44%）。 Batch Disposition 批次处置• Batch re-inspection due to particulates appears to be a common practice: 43% have re-inspected one to five batches per year, and 18% have re-inspected more than 10 batches per year. • 因发现颗粒物而进行批次再检查是很常见的一件事：43%的受访者每年需要对1-5批次进行再检查，18%每年进行再检查的批次会超过10批。 • Fifty percent (50%) of respondents further indicated that, in the last year, they had batches rejected for particulate matter; 32% of those had one to three batches rejected, and the remainder had more than three batches rejected. • 50%的受访者还表示在上一年因颗粒物拒绝批次放行，32%拒绝过1-3批，而其余的则超过3个批次被拒绝放行。 • Forty-four percent (44%) of respondents reported having received customer complaints due to particulate matter. • 44%的受访者表示因颗粒问题收到过客户投诉。 • Twenty-six percent (26%) of respondents reported having received observations from regulators related to particulate control. • 26%的受访者因颗粒物控制相关的问题收到过监管机构意见。 • Approximately 9% of respondents reported having one or more batches recalled for particulate matter in a finished product during the previous year. • 大约9%的受访者表示在上一年因成品中的颗粒物问题找回了一个或多个批次。 Elastomeric Primary Components 人造橡胶外包装组件• Some (45%) of the respondents have their supplier pre-wash elastomeric components to remove particulate matter. This indicates that nearly half of the parenteral industry places the control of final closure particle burden on component manufacturers. • 45%受访对象的供应商预洗了人造橡胶成分，以去除颗粒物。这表明近一半的非经胃肠道制造业将最终封闭系统的颗粒物控制权交给了组件制造商。 • The method used to test for visible particulate matter in elastomeric components was reported by 20% as ISO 8871, a membrane microscopic approach (12). • 用于测试人造橡胶组件中可见颗粒物的方法中，ISO 8871所描述的方法占20%，级膜显微法（12）。 • Roughly half (49%) tested for visible particulate matter by an AQL sampling plan using only visual inspection. • 大约一半（49%）的AQL抽样计划使用目视检查法进行可见颗粒物测试。 Glass Primary Component 玻璃外包装组件• Some 32% of respondents reported having an external supplier wash product containers to reduce particulates. • 32%的受访者表示拥有外部供应商进行产品容器洗涤以减少颗粒物。 • Seventy percent (70%) of respondents that wash their own containers reported using visual inspection procedures for particle control of washed/processed containers. • 70%受访者表示，他们使用目视检查程序对已经洗涤/加工过的容器进行颗粒控制，从而清洗容器。 • Thirty-one percent (31%) perform 100% inspection prior to filling. • 31%的受访者会在灌装前进行100%检查。 • Thirty-eight percent (38%) utilize statistical AQL visual inspection only on the cleaned containers upon batch receipt. • 38%的受访者在验收批次时，仅对清洁的容器使用统计AQL目视检查。 3.2 Lifecycle Management 生命周期管理Particulate lifecycle management is essential for maintaining control of DIP products, which includes routine characterization and defect monitoring. The lifecycle elements for DIP products may take several years to implement in order to achieve visible particulate levels similar to those for clear liquid solutions. 颗粒物生命周期管理对于DIP产品的持续控制至关重要，其中包括常规鉴别和缺陷监控。对于DIP产品，其生命周期要素可能需要花费数年时间才能实现，才能达到类似于透明液体溶液的可见颗粒物水平。 A key message taken from the PDA 2015 Particulate Matter in DIPs survey is that the industry as a whole must begin to take planned short- and long-term actions to develop lifecycle control processes for DIP products, focusing on API, raw materials, components, and in-process fill/finish controls. For all pharmaceutical sterile production pathways, including but not limited to those areas listed below, an evaluation of the particle load and contribution is an essential step in the lifecycle of product improvement. 2015年PDA发布的DIP产品中的颗粒物调查中有一项重要的信息是，整个行业必须开始采取有计划的短期和长期行动，以建立DIP产品的生命周期控制流程，集中于API、原材料、组件、以及在线灌装/灌封控制。对于所有制药无菌生产途径，包括但不限于以下所列出的领域，对于颗粒负载和影响性的评估是产品改进的生命周期中必不可少的一步。 • Drug substance 药物 • Excipients 辅料 • Vehicle 载体 • Packaging – container 包装-容器 • Packaging – closure 包装-密闭器 • Air quality of controlled environments 受控环境的空气质量 • Personnel contribution 人员影响 • Washing – effectiveness or cleanliness of: 清洗-效果或清洁度： – Containers – 容器 – Closures – 密闭器 – Equipment – 设备 – Expendables including: tubing, wipers, sterile wraps, bags, etc. – 消耗品包括：管道、擦拭物、无菌包装纸、袋子等。 Section 6.0 provides further discussion on considerations for lifecycle management of DIP products. 第6.0节提供了关于DIP产品生命周期管理注意事项的进一步讨论。
补充内容 (2020-11-24 11:06):
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换到了ISPE Vol3 无菌生产 3rd
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换到了 ISPE Vol 4 水和蒸汽 第三版；Vol 7 MAPP 第二版；contamination handbook 2016； | 
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