Issue link: https://www.e-digitaleditions.com/i/1199406
34 January 2020 Tablets & Capsules lines the quality requirements for the types of equip- ment already in-house. The VMP defines the systems, equipment, methods, and facilities that are in the scope of the plan; compliance requirements for validation, including how the validated state will be maintained; required validation deliverables; and the validation risk-mitigation strategy. Equipment-specific validation protocols must follow the requirements of the VMP whether written in-house or provided by the equipment manufacturer or installa- tion company. Regulatory agencies commonly observe deviations f rom the VMP requirements on audits, because companies too often approve the equipment manufacturer's validation protocols without carefully comparing them to the VMP. Equipment change control should reference the requirements for calibration and validation detailed in the VMP. The challenge arises when a company purchases a state-of-the-art piece of equipment that is not within the scope of the VMP. In this case, the most compliant and thorough course of action is to review the equip- ment manufacturer's validation package and identify IQ, OQ, and PQ gaps for the equipment's intended use. The equipment change control should reference both the manufacturer's validation package and the gap validations that you will perform. Note that in all cases, the equipment owner as well as validation and quality personnel must approve the man- ufacturer's validation protocols and your internal gap validation protocols prior to execution. You should also update the VMP to include the valida- tion requirements for the new equip- ment and document these deliverables in the equipment change control. 5. Review/approval of turnover packages, executed validation data/reports and release of equipment for GMP use Some companies often treat this stage in the change control process as a rubber-stamp activity, but it is an extremely critical phase, where you can identify and remedy issues, gaps, deviations, and deficiencies with input from personnel in quality, engineer- ing, validation, and the department owning the equipment. The endgame is not just to sign off and archive validations and their change control documentation, but also to prepare for inspection by regulatory authorities. As such, companies should not rush this stage of the process or simply rubber stamp the process as approved. A common mistake companies make is to forget to complete a written statement, approved by all par- ties, including quality personnel, that the equipment is released for GMP use. Although all of the associated val- 3. Assessing the new equipment's impact on utility validations Once you've determined the existing utility capacity and compared it to the new equipment requirements, assess whether installing the new equipment will affect previously executed utility validations. If the installation and functionality of new equipment requires adding new utility points of use (POU) to connect the equipment to the utility, you will need to update the drawings, sche- matics, and materials of construction detailed in the util- ity's installation qualification (IQ) and assign new piping and instrumentation diagram numbers to the POU. Tied to this change, the operational qualification (OQ) will likely require revision to test the functionality of the new POU and, for gas systems, a pressure-hold challenge will be required. Performance qualification. The performance qual- ification (PQ) tests the ability of the utility to perform consistently over long periods of time within tolerances deemed acceptable by the manufacturing process as a whole and should include challenging the utility while under a load comparable to that expected during routine production. This is the most important element to test when connecting new equipment to an existing utility because it confirms whether the utility will be able to keep up with demand while all POU are in operation serving equipment. For example, consider a CDMO that is adding a large commercial-scale spray dryer to its current collection of three small-scale spray dryers. The CDMO plans to use all of the spray dryers simultane- ously to manufacture sponsor prod- ucts and requires the use of pharma- ceutical-grade nitrogen. The ability of the nitrogen system to keep up with demand is essential, as the qual- ity of sponsor products and timelines for deliverables is paramount to the CDMO's success. Repeating part or all of the nitrogen's PQ while operating all spray dryers simultaneously pro- vides documented evidence that the nitrogen system will meet the require- ments of all connected equipment. 4. Equipment installation and calibration/validation When calibrating equipment, it is important that the calibration match or exceed the intended operational range of the equipment that will be used during actual production activities. Too often, equipment is oper- ated at rpm, flow rates, compression forces, or other set- tings outside the calibrated range of the equipment. This is a common audit observation made in sponsor and regula- tory inspections of production facilities. Requirements for validating equipment should be detailed in a validation master plan (VMP) that out- A common mistake companies make is to forget to complete a written statement, approved by all parties, including quality personnel, that the equipment is released for GMP use.