A Brief about WHO GMP (Good Manufacturing Practices)

A Good Manufacturing Practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

The implementation and enforcement of Good Manufacturing Practices (GMP) in Blood and Plasma Collection Establishments is considered a priority as a tool to minimize the risk of transmitting currently known and emerging blood-borne diseases. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products.

In the U.S. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guideline. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

GMP is a system for ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by the product specification. A Comprehensive explanation about ‘Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce’ is explained on www.who.int.