【正文】 include a review of pertinent maintenance procedures, repair parts lists, and calibration methods for each piece of equipment. The objective is to assure that all repairs can be performed in such a way that will not affect the 7 For example, the AAMI Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices approved 2 December 1981, states: The performance qualification should include a minimum of 3 successful, planned qualification runs, in which all of the acceptance criteria are met.....(.). 16 characteristics of material processed after the repair. In addition, special postrepair cleaning and calibration requirements should be developed to prevent inadvertent manufacture a of nonconforming product. Planning during the qualification phase can prevent confusion during emergency repairs which could lead to use of the wrong replacement part. b. Process: Performance Qualification The purpose of performance qualification is to provide rigorous testing to demonstrate the effectiveness and reproducibility of the process. In entering the performance qualification phase of validation, it is understood that the process specifications have been established and essentially proven acceptable through laboratory or other trial methods and that the equipment has been judged acceptable on the basis of suitable installation studies. Each process should be defined and described with sufficient 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