Quality control can be tricky. A pharmaceutical company may wish to make a claim about a product about to go on the market and even back up the claim with concurrent lab results that are difficult to scientifically verify. Fortunately, good manufacturing practices and good laboratory practices ensure that this does not happen. GMP and GLP regulations promote accountability via documentation and strive to keep quality and integrity in the forefront of all product testing and research.
Testing Facilities and Buildings
According to GMP and GLP written rules and regulations, all buildings used in the processing, manufacturing or packing of any pharmaceutical product must be suitably sized and located to facilitate maintenance, cleaning and proper operation. Facilities must be designed to keep separate all testing areas, so as to ensure that no lab results can be affected by accidental mishaps. Proper lighting, plumbing, sewage, washing and toilet facilities and maintenance areas must be built. In addition, companies abiding by these rules promise to provide equipment for control over air pressure, dust, micro-organisms, temperature or humidity, if needed.
Testing Facility Operations
All testing facilities must have written standard operating procedures in place to define nonclinical study methods in laboratory settings. Written rules are vital so that the quality and integrity of the information studied is ensured. Facilities that house animals for testing must keep animals of different species in separate rooms when necessary. Animals of the same species, who are being used in different studies, cannot be kept in the same room, ensuring that no animal mix-up could affect lab results. If mixed housing is absolutely necessary, then adequate measures must be put in place so that all animals can be easily identified according to the study to which they belong.
All personnel who deal with the processing, manufacturing or packing of a pharmaceutical product must have the required training, education and experience. There are three key job titles. The first is the study director, who must be a scientist responsible for the technical conduct of the product study itself. The second is the quality assurance unit, responsible for monitoring each study to ensure that the equipment, facilities, staff, test methods and documentation conform to written regulations. The third, the testing facility management, is essentially the bosses from whom the orders originate.
Equipment used in the manufacture, processing or packing of a pharmaceutical product must be of appropriate design, adequately sized and located suitably so that the intended use, cleaning and maintenance can be carried out. All equipment, such as computers and manufacturing machines, must be routinely inspected, calibrated and checked according to written regulations designed to ensure proper performance. Written records of all inspections, calibrations and checks must be kept for management review.
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