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Tablets & Capsules January 2020 35 idation and calibration documentation may be approved, inspectors from regulatory agencies around the world look for this designation that the equipment is suitable and released for GMP activities. 6. Evaluation of the effectiveness of the equipment change control An effectiveness check is a valuable way to identify where equipment commissioning gaps and problems may exist and also for formulating a plan to prevent the same issues from occurring during future activities. In practice, companies rarely perform this evaluation, as the staff members involved in the change control are generally quickly redirected to the next new piece of equipment to commission. As a result, companies tend to repeat the same failures over and over unless a robust change con- trol effectiveness check is built into the equipment com- missioning process as a required step. Takeaway New production equipment can be exciting to the end user. It is often seen as a stainless-steel marvel that provides technical capabilities and increased processing speed that was not previously available. However, such equipment is often far from plug-and-play. In many cases, the equipment will impact the electrical, gas, water, drainage, heating, and cooling utilities servicing a wide array of equipment in the GMP setting. The six stages of equipment change control discussed in this article provide a detailed roadmap for evaluating a facility's current capabilities and comparing them to the requirements of new equipment. Careful evaluation, planning, and direct input from engineering, validation, and quality departments, can help you avoid the common pitfalls associated with installing new equipment. T&C References 1. https://ec.europa.eu/health/sites/health/files/files/ eudralex/vol-4/2015-10_annex15.pdf. 2. US FDA, "Guidance for industry: Quality systems approach to pharmaceutical cGMP regulations," Septem- ber 2006. Greg Weilersbacher is an independent consultant with EAS Consulting Group (easconsultinggroup.com), a provider of comprehensive regulatory consulting, training, and auditing services to the dietary supplement, pharmaceutical, food, medi- cal device, tobacco, and cosmetics industries. Weilersbacher has 25 years of industry experience managing quality assur- ance, quality control, analytical development, materials man- agement, GMP manufacturing, GMP facilities and utilities validation, and facility design and construction management in CMOs, biotech firms, and pharmaceutical companies.