What does GMP stand for?
GMP is essential within the quality system to ensure that medicines are produced consistently and in accordance with strict quality standards. It comprises a set of rules that guarantee that medicines are safe and effective, to prevent incidents such as the historic Softenon scandal, in which thousands of babies were born with birth defects after exposure to the teratogenic drug thalidomide in the 1950s.To prevent such tragedies, laws and guidelines were introduced in the U.S. in 1978 and in Europe in 1989, requiring that medicines undergo rigorous testing before being brought to market. GMP guidelines play a crucial role in this by specifying in detail how and under what conditions drugs are manufactured. This includes the meticulous control of raw materials, intermediate products, and finished products, ensuring that the process is fully traceable. GMP ensures that medicines are safe, authentic, effective, and free from contaminants, which is essential for patient safety.
What does GMP entail?
GMP requires that every employee performing GMP activities (manufacturing, storage, quality control, and all activities that may affect product quality) have the appropriate level of training. All training for each employee must be documented, and every employee must be trained in the most current procedures. In addition, all processes must be clearly described in procedures. The purpose of a documentation system is to control, monitor, and document all production-related activities that may have a direct or indirect impact on the quality of the medicinal product. Appropriate controls must be implemented to ensure that correct and accurate documents are created and made available to the individuals who need them for their work. Any deviation or change to a GMP procedure must be formally documented.
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