【正文】 specificity so that employees understand what is required. 17 Parts of the process which may vary so as to affect important product quality should be In challenging a process to assess its adequacy, it is important that challenge conditions simulate those that will be encountered during actual production, including worst case conditions. The challenges should be repeated enough times to assure that the results are meaningful and consistent. 8 For example, in electroplating the metal case of an implantable pacemaker, the significant process steps to define, describe, and challenge include establishment and control of current density and temperature values for assuring adequate position of electrolyte and for assuring cleanliness of the metal to be plated. In the production of parenteral solutions by aseptic filling, the significant aseptic filling process steps to define and challenge should include the sterilization and depyrogenation of containers/closures, sterilization of solutions, filling equipment and product contact surfaces, and the filling and closing of containers. 18 Each specific manufacturing process should be appropriately qualified and validated. There is an inherent danger in relying on what are perceived to be similarities between products, processes, and equipment without appropriate c. Product: Performance Qualification For purposes of this guideline, product performance qualification activities apply only to medical devices. These steps should be viewed as preproduction quality assurance activities. 9 For example, in the production of a pressed tablet, a 9 For example, in the production of a pressed tablet, a firm may switch from one type of granulation blender to another with the erroneous assumption that both types have similar performance characteristics, and, therefore, granulation mixing times and procedures need not be altered. However, if the blenders are substantially different, use of the new blender with procedures used for the previous blender may result in a granulation with poor content uniformity. This, in turn, may lead to tablets having significantly differing potencies. This situation may be averted if the quality assurance system detects the equipment change in the first place, challenges the blender performance, precipitates a revalidation of the process, and initiates appropriate changes. In this example, revalidation prises installation qualification of the new equipment and performance qualification of the process intended for use in the new blender. 19 Before reaching the conclusion that a process has been successfully validated, it is necessary to demonstrate that the specified process has not adversely affected the finished product. Where possible, product performance qualification testing should include performance testing under conditions that simulate actual use. Product performance qualification testing should be conducted using product manufactured from the same type of production equipment, methods and procedures that will be used for routine production. Otherwise, the qualified product may 。s characteristics, such as uniformity and identity. The following are considered as key elements of prospective validation.4 For example, in order to assure that an oral, ophthalmic, or parenteral solution has an acceptable pH, a specification may be established by which a lot is released only if it has been shown to have a pH within a narrow established range. For a device, a specification for the electrical resistance of a pacemaker lead would be established so that the lead would be acceptable only if the resistance was within a specified range. 13 1. Equipment and Process The equipment and process(es) should be designed and/or selected so that product specifications are consistently achieved. This should be done with the participation of all appropriate groups that are concerned with assuring a quality product, ., engineering design, production operations, and quality assurance personnel. a. Equipment: Installation Qualification Installation qualification studies establish confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances. After process equipment is designed or selected, it should be evaluated and tested to verify that it is capable of operating satisfactorily within the operating limits required by the This phase of validation includes examination of equipment design。 performance characteristics may include bioavailability (reflected by disintegration and dissolution). In the case of blood tubing, ph