Quality Management System(QMS) in Pharmaceutical Industry

Quality Management System (QMS) in pharmaceutical industry Course DetailsClass -1: Introduction on QMS Class -2: Discussion on deviation handling Class-3: Discussion on Out of specifications and out of trends Class-4: Discussion on Change control handling Class-5: Discussion on handling of market complaints Class-6: Root cause investigation and methodologies 1 Class-7: Root cause investigation and methodologies 2 Class-8: Risk management Class-9: Corrective actions and preventive actions and Effectiveness monitoringA Pharmaceutical Quality Management System (QMS) develops and ensures quality procedures in various product life cycle stages such as manufacturing and product testing. It includes all the critical stages of drug manufacturing, including:FormulationMethod developmentFacilitiesUtility systemEquipmentIt ensures that the final product is according to customer requirements, as well as regulatory requirements which the manufacturer is obliged to follow. It uses monitoring methods such as Quality Assurance to prevent quality deviation and emphasizes quality system documentation to record all problems and their solutions.

Current Good Manufacturing Practice (cGMP)cGMP is a regulation enforced by the Food and Drug Administration (FDA), the US federal agency is responsible for safe production of drugs. The cGMP focuses on the manufacturing process. The product must be safe for human consumption, with quantity, quality, and purpose taken into consideration.

The output must be free from contamination, risk, and most importantly, prevent mix-up of one product with another product. The FDA inspects its accredited manufacturers for cGMP compliance. If FDA finds non-compliance with cGMP regulation and serious drug adulteration, the manufacturer is directed to recall the product.

Failure to follow the subsequent FDA directions can result in seizure, fines, and jail time. Role of Quality Management System (QMS) in the Pharmaceutical IndustryIn the Pharmaceutical Industry, the Quality Management system (QMS) is an important aspect as the quality of the pharmaceutical products or the drugs is very critical and important as it defines the quality, purity, meeting specification, and safety which is finally involved when it is related to about life and in demand of today's scenario. Quality management system in the pharmaceutical industry is a continuous, innovative, and documented process that plays an important role because of the criticality of the various functions involved and also opting for quality management system software.