Validation, qualification and calibration are not just one-off activities. They must be carried out on an on-going basis if a facility’s development, operation and maintenance are going to continue to meet all regulatory requirements. Validation involves the collection and analysis of data in a systematic manner that proves that an analytical method or manufacturing process will give consistent results that meet all specifications when carried out in the prescribed manner. Qualification is the analogous term for equipment and machinery. Installation qualification (IQ) is performed for new equipment, and operation qualification (OQ) and performance qualification (PQ) monitor the day-to-day running of that equipment.
The validation of computer systems must not be overlooked. The computer system validation (CSV) process is used to ensure that all IT applications adequately fulfill their intended purpose. CSV is an important element of the facility’s validation master plan, and all the documentation necessary for equipment must also be prepared for computer systems—much of the data they handle is relevant to a GMP process, and thus, any failure can have a negative impact on product quality. The complexity of such computer systems means an even more in-depth validation process is appropriate, backed up by a methodical risk analysis that allows validation efforts to be focused on the most critical aspects of the system.
All phases of design, development, testing and the software’s routine use must be controlled throughout the lifecycle of a computerized system if it is to remain properly validated. This is particularly important in biopharmaceuticals, as GMP demands specific controls and procedures. CSV includes every activity involved in the application of appropriate controls and procedures throughout the software development lifecycle, and creating all the documentation required by the regulators.
Calibration, meanwhile, is vital in proving and maintaining the legitimacy of qualification and validation. It is designed to show that any instrument or device gives results that fall within specified limits, in contrast to results produced using a traceable standard over a suitable range of measurements. Calibration must be carried out using qualified instruments by an accredited laboratory.
Accurate calibration is essential when building a solid quality management system using experts and qualified specialists. Companies will frequently seek outside support, particularly when upgrading, refurbishing and constructing new facilities, and when sourcing and installing new equipment. These external experts are ideally placed to carry out factory and site acceptance tests. Factory acceptance tests incorporate an inspection, and involve both dynamic and static testing of systems and their major components to support the qualification of equipment. This takes place at the supplier’s site before it is shipped to the end-user. Site acceptance tests, meanwhile, are similar, with the major difference being that they are carried out where the equipment is to be used.