What does “good manufacturing practice” or GMP entail?

Good Manufacturing Practice (GMP) encompasses regulations that ensure that products are consistently produced and controlled according to quality standards. This set of regulations is crucial in the manufacturing processes of pharmaceuticals, medical devices, and other products, as it helps minimize the risks involved in production that cannot be eliminated through testing the final product alone.

GMP dictates that manufacturers must establish a quality management system that includes documented procedures and processes, adequate training of personnel, and detailed records of manufacturing history. These practices lead to the minimization of errors and defects while ensuring products meet quality and safety expectations. Upholding GMP is essential to protecting public health by ensuring that medical and pharmaceutical products are produced under rigorous criteria, maintaining their integrity throughout the supply chain.

The other choices relate to different aspects of regulatory affairs. Standards for marketing medical devices focus on aspects such as labeling, advertising, and promotional activities; guidelines for clinical trial management pertain to how clinical studies are conducted, including participant safety and data integrity; and procedures for post-market surveillance involve monitoring products after they are released to the market to identify possible issues. However, these do not address the core focus of GMP, which is the quality and consistency of the manufacturing process itself.