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Tablets & Capsules January 2020 29 In practice, many companies limit change control to documentation such as batch records, standard operating procedures, protocols, and specifications, while handling equipment and facilities change control in isolation, if at all. As a result, new equipment is often installed and con- nected to utilities without prior input and approval from facilities, engineering, validation, and quality personnel. While many in the pharmaceutical industry may con- ceptually understand change control for equipment and facilities, most lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which the equipment connects. This article provides a detailed framework that companies can use to design compliant equipment change control procedures. Scope of change control Equipment change control (ECC) applies to all GMP and non-GMP equipment that connects to a facility's GMP utilities. Utilities include 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 indi- rect impact on cleanroom operations. Non-GMP equip- ment is included in ECC because the utilities are shared. If you are fortunate, your compa- ny's R&D departments are located in buildings with utilities dedicated to research activities. However, many companies must share buildings and utilities between R&D and GMP oper- ations. In such cases, any time a piece of equipment (R&D or GMP) is con- nected to a shared utility, it has the potential to affect the performance of other equipment connected to the utility or even 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 to assume that the utility you intend to connect to is dedicated to R&D. ECC can be grouped into six pri- mary stages: (1) determining the new equipment's utility/IT requirements; (2) comparing the new equipment utility requirements to existing utility capabilities; (3) assessing the new equip- ment's impact on utility validations; (4) equipment instal- lation, validation/calibration; (5) review/approval of turn- over packages, executed validation data/reports, and release of equipment for GMP use; and (6) evaluation of the effectiveness of the equipment change control. 1. Determining the new equipment's utility/IT requirements The starting point for ECC, and one of its most important steps, is to determine the new equipment's util- ity and IT requirements. It's critical to detail the equip- ment's utility requirements before purchasing the equip- ment because the cost of purchasing the equipment can often double when you include utility upgrades and other related equipment purchases required to ensure the desired equipment's proper operation. You can find the utility requirements in the owner's manual or directly from the equipment manufacturer. The manufacturer can often provide specification sheets detailing the equipment's requirements for electrical, venting/exhausting, heat dissipation or cooling, water quality, clean gases, clean steam, drainage, and explosion proofing. The specification sheet should also include a list of materials of construction that is critical for prod- uct-contact equipment used in GMP manufacturing. It's 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 of impacted utilities. The need to connect new equipment to GMP servers and networks is often overlooked. Equipment configured with outputs that can be connected to GMP servers is now the norm for new instruments and represents one of several methods for ensuring the integrity of electronic data. However, companies often encounter problems when purchasing used and refurbished equipment that the manufacturer orig- inally designed as stand-alone equip- ment without networking capabilities. Data integ rit y compliance doesn't vanish when equipment is unable to connect to validated networks. Such equipment creates compliance issues that your company must develop a plan to address. 2. Comparing the new equipment utility requirements to existing utility capabilities Electrical. To determine if an elec- tric utility is capable of meeting the needs of your new equipment, facili- ties personnel will first need to know where it will be installed. This seems obvious, but too often those who pur- chase equipment don't know exactly where the new equipment will be installed. A common response is that the equipment "will be put in one of the cleanrooms." That can be a problem because it's unlikely that each cleanroom is configured exactly the same in terms of the type of power available and the number of connections. If the equipment requires a significant power draw, the circuit panel will need to be evaluated to ensure that the panel is not only fed by the right power supply but is also balanced, meaning that the total amperage requirements of the electrical equipment in a shared-neutral installa- tion is distributed equally among the number of available electrical circuits servicing the installation. Obviously, 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 or even damage the utility.