What is GMP?

Good Manufacturing Practice (GMP) plays a crucial role in the pharmaceutical industry. But what exactly does GMP entail? This blog offers a detailed explanation of this essential aspect.

What does GMP mean?

GMP is essential within the quality system to ensure that medicines are consistently produced according to strict quality standards. It encompasses a set of rules that guarantee that medicines are safe and effective, aiming to prevent incidents like the historical Thalidomide scandal, where thousands of babies were born with birth defects after being exposed to the teratogenic drug in the 1950s. To prevent such tragedies, laws and regulations were introduced in 1978 in the U.S. and in 1989 in Europe, requiring that medicines undergo rigorous testing before being released to the market. GMP guidelines play a key role in this process by detailing how and under what conditions medicines should be produced. This includes strict control of raw materials, intermediates, and final products, making the entire process fully traceable. GMP ensures that medicines are safe, intact, effective, and free from contamination, which is essential for patient protection.

What does GMP involve?

GMP requires that every employee involved in GMP-related activities (production, storage, quality control, and any activity that may affect product quality) must have the appropriate level of training. All employee trainings must be documented, and each employee must be trained according to the most current procedures. In addition, all processes must be clearly described in written procedures. The purpose of a documentation system is to control, monitor, and record all production-related activities that have a direct or indirect impact on the quality of the medicinal product. Suitable controls must be in place to ensure that correct, accurate documents are created and available to the personnel who need them for their tasks. Every deviation and change from a GMP procedure must be formally documented.