Equipment Change Control For GMP Production Facilities本文来自pharmaceuticalonline文章翻译 Annex 15 of the EU GMP Guidelines defines “change control” as: “A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes.” The FDA’s own guidances refer to change control as “…managing change to prevent unintended consequences.” In practice, however, many companies limit change control to documentation such as batch records, SOPs, protocols, and specifications, while change control for equipment and facilities, if done at all, is minimized and handled in isolation. That is, when new equipment arrives, it is installed and connected to utilities without prior input and approval from facilities, engineering, validation, and quality. While many in the industry may conceptually understand change control for equipment and facilities, most people lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect. This article is the first in a two-part series providing a detailed framework that can be used by companies in the design of compliant equipment change control procedures. 欧盟GMP指南附件15将“变更控制”定义为：“一个正式的体系，通过该体系，适当部门的有资质代表对可能影响设施、系统、设备或流程验证状态的提议或实际变更进行评审。”FDA的指南将变更控制称为'... 管理变更以防止意外后果。' 然而，在实践中，许多公司将变更控制限制在批记录、SOP、协议和质量标准等文件中，而对设备和设施的变更控制(如果有的话)则被最小化并单独处理。也就是说，当新设备到达时，它被安装并连接到公用事业，而无需事先得到设施、工程、验证和质量的输入和批准。虽然行业中的许多人可能在概念上理解设备和设施的变更控制，但是大多数人缺乏将这种控制应用于高度复杂的设备及其连接的实用程序的知识。本文是由两部分组成的系列文章的第一篇，提供了一个详细的框架，可以供公司在设计符合要求的设备变更控制程序时使用。 The Scope Of Change Control变更的范围 Equipment change control (ECC) applies to equipment from all departments (GMP and non-GMP) that connect to the facility’s GMP utilities. This includes utilities such as electrical, water systems, drainage, clean gases, venting/exhausting of heat and fumes, equipment cooling, clean steam, GMP servers and networks, HVAC, and any system that has direct or indirect impact on cleanroom operations. Why include non-GMP equipment in ECC? The answer is simple: shared utilities. 设备变更控制(ECC)适用于与工厂GMP公用设施相连接的所有部门(GMP和非GMP)的设备。这包括公用工程，如电、水系统、排水、清洁气体、排热排烟、设备冷却、清洁蒸汽、GMP服务器和网络、HVAC，以及对洁净室操作有直接或间接影响的任何系统。为什么ECC中包括非GMP设备? 答案很简单：共用公用系统。 If you are one of the fortunate ones, your company’s research and development (R&D) departments are located in buildings with utilities dedicated to research activities. The rest of us, however, must share buildings and utilities between development and GMP operations. As such, any time a piece of equipment (R&D or GMP) is connected to a shared utility, it has the potential to affect the performance of other equipment connected to the utility. It also has the potential to damage the utility. This is why ECC is so important and where it shows its value. One of the biggest errors you can make is assuming that the utility you intend to connect to is dedicated to R&D. 如果你是幸运的，你的公司的研发(R&D)部门位于配备了研究活动专用公用系统的建筑物。然而，我们其他人必须在开发和GMP操作之间共享建筑物和公用设施。因此，任何时候一个设备(R&D或GMP)连接到一个公用系统，它都有可能影响其他连接到公用系统的设备的性能。它也有可能损害公用系统。这就是ECC如此重要的原因，也是它的价值所在。您可能犯的最大错误之一是假设您打算连接的公用系统是专用于研发的。 Equipment change control can be grouped into six primary stages, each with several sub-stages: (1) Determining the equipment utility/IT requirements, (2) Pre-installation assessment, utility evaluation, and remediation, (3) Assessing the impact of equipment installation and operation on the validation of the utility, (4) Equipment installation, validation/calibration, (5) Review/approval of turnover packages, executed validation data/reports, and release of equipment for GMP use, and (6) Evaluation of effectiveness of the equipment change control. 设备变更控制可分为六个主要阶段，每个阶段有几个子阶段： (1) 确定设备设施/IT要求； (2) 安装前评估、公用系统评估和补救; (3) 评估设备安装和运行对公用系统验证的影响; (4) 设备安装、验证/校准; (5) 提交文件的审核/批准、执行的验证数据报告、GMP设备的放行; (6) 评估设备变更控制的有效性。 Stage 1: Understanding The Utility And IT Requirements For New Equipment 阶段1：理解新设备的公用系统/IT要求 This is the starting point for ECC and is one of the most important steps. Before the equipment is purchased, you must detail the equipment’s utility requirements. “Before you purchase” must be emphasized here, because all too often the cost of purchasing the equipment doubles, as does the commissioning timeline when utility upgrades and other related equipment purchases are needed to ensure proper operation of the equipment you wish to buy. 这是ECC的起点，也是最重要的步骤之一。在购买设备之前，你必须详细说明设备的使用要求。'在您购买之前'必须在这里强调，因为购买设备的成本经常翻倍，当需要进行公用系统升级和其他相关设备购买以确保您想购买的设备的正常运行时，调试时间表也是如此。 The answer can be found from several sources, including the owner’s manual or directly from the equipment manufacturer. The manufacturer often can provide specification sheets that detail the equipment’s requirements for electrical, venting/exhausting, heat dissipation or cooling, water quality, clean gases, clean steam, drainage, and explosion proofing. The spec sheet should also include a list of materials of construction that are critical for product contact equipment used in GMP manufacturing. It is important to determine the requirements for each utility when the equipment is operating at full capacity. Your company’s engineers and facility mechanics can be a great resource in helping you come up with an exhaustive list. 答案可以从几个来源找到，包括业主手册或直接从设备制造商。制造商通常可以提供规格表，详细说明设备在电气、送/排风、散热或冷却、水质、清洁气体、清洁蒸汽、排水和防爆方面的要求。规格表还应包括对GMP制造中使用的产品接触设备至关重要的施工材料清单。当设备满负荷运行时，确定每个实用程序的需求是很重要的。你的公司的工程师和系统机械师是一个很好的资源，可以帮助你列出一个详尽的清单。 An often-overlooked need is the connections to GMP servers and networks. Equipment configured with outputs that can be connected to GMP servers is now the norm for new instruments. This represents one of several elements in ensuring data integrity of electronic records. However, problems are often encountered when purchasing used and refurbished equipment that the manufacturer originally designed as stand-alone equipment without networking capabilities. Data integrity compliance does not vanish when equipment cannot connect to validated networks. It creates compliance issues for which your company must develop a plan to address.一个经常被忽视的需求是与GMP服务器和网络的连接。配置输出可连接到GMP服务器的设备现在是新仪器的标准配置。这是确保电子记录资料完整的其中一项要素。然而，在购买制造商最初设计为没有联网功能的独立设备的二手和翻新设备时，经常会遇到问题。当设备无法连接到经过验证的网络时，数据完整性的符合性不会消失。它会产生符合性问题，您的公司必须为这些问题制定一个解决方案。 |
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