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Good manufacturing practices are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. GMP focuses attention on five key elements, which are often referred to as the 5 P's of GMP—people, premises, processes, products and procedures (or paperwork). It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
In US, FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.
The GMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
for Food and Dietary Supplements, GMP regulations generally address matters including appropriate personal hygienic practices, design and construction of a food plant and maintenance of plant grounds, plant equipment, sanitary operations, facility sanitation, and production and process controls during the production of food.
Benefits of the GMP
Pharmaceutical companies are required by law to have GMPs in place. It helps ensure consistent, acceptable product quality and safety. An effective GMP reduces risk, helps companies save money, upholds a company’s reputation and helps to create a competitive edge in an increasingly crowded marketplace.
Implementing GMPs as early as possible in the development of a drug helps protect the safety of clinical trial participants and provides a foundation for a robust quality management system (QMS).
To know more and get information on Current Good Manufacturing Practice (CGMP) regulations, schedule a free 30-minute consultation with an IBEC expert.