Pharmaceutical quality control methods include inspections, adhering to SOPs, and product testing. Gas chromatography-mass spectrometry is a common method. FDA enforces strict rules and procedures for drug manufacturers. Employees must follow guidelines and maintain records. Counterfeit drugs are a concern. Consumers should research drug companies before purchasing.
The different pharmaceutical quality control methods include, but are not limited to, inspections conducted by government agencies, drafting and adhering to a detailed standard operating procedure (SOP), and periodic collection and testing of products by company employees. Inspection of pharmaceutical company facilities and product testing by outside agencies are among the best quality control methods. Pharmaceutical quality control involves ensuring the cleanliness of facilities, the calibration and efficiency of laboratory equipment, workers’ adherence to procedures, and the degree of purity of ingredients.
A common method of pharmaceutical quality control is gas chromatographic mass spectrometry. Gas chromatography-mass spectrometry involves subjecting a mixture, such as a drug or medication, to a chemical analysis in which the unique signature and amount of each substance in the drug is identified and displayed. This test will tell you exactly how much of the specific chemicals are in the product. While this is just one of several pharmaceutical quality control methods, gas chromatography-mass spectrometry is highly accurate and relatively simple to perform.
Companies that manufacture drugs for sale and distribution in the United States are subject to strict rules and procedures enforced by the Food and Drug Administration (FDA). Companies must register and list every active pharmaceutical ingredient in commercial distribution. Additionally, the FDA requires pharmaceutical companies to control and monitor all possible means of product contamination, both microbial and chemical, in the SOP.
Employees working in the manufacturing of pharmaceuticals must know and follow the established laboratory guidelines as clearly stated in the SOPs. One of the most important of these is careful attention to record keeping and laboratory records. These records are carefully reviewed during inspections. Employees are expected to have a working knowledge of all analytical procedures and to fully perform them with fidelity. Hand washing and the use of lab aprons and gloves would be typical procedures workers would follow to ensure quality control.
While many pharmaceutical companies have high standards of quality control and make every effort to deliver a great product, this is not always the case. The integrity of a pharmaceutical manufacturer is not a guarantee and counterfeit drugs are manufactured and are able to be sold in reputable pharmacies. Inspectors are often behind schedule and don’t visit a business for months at a time, and businesses with violations are usually fined and given warnings before being forced to close. It never hurts to ask your pharmacist which drug companies he orders from, and then do a little research on those companies’ reputations before buying a drug.
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