Since the early 1990s, regulatory agencies and drug firms have understood the benefit of regulations that are "harmonized". Different regulatory agencies around the world have arrived at a common set of requirements.

The International Conference on Harmonization or ICH is the group of regulatory officials and industry experts from the EU, Japan, and the US that are working on this. One of the four sets of documents, those dealing with "quality," are most related to GMP topics. The first set of GMPs that have international acceptance are those for active pharmaceutical ingredients (APIs).

GMPs of various nations are very similar; most require things like- equipment and facilities being properly designed, maintained, and cleaned; Standard Operating Procedures (SOPs) be written and approved; an independent quality unit (like quality control and/or quality assurance); and well-trained personnel and management.

Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing human pharmaceutical products and veterinary products, biologically derived products and medical devices.

The US pharmaceutical product regulations are called "current" good manufacturing regulations or "cGMPs", to emphasize that the expectations are dynamic. GMPs define a quality system that manufacturers use as they build quality into their products.

Originally, GMPs were based upon the best practices of the industry. As technology and practices improved, the GMPs evolved as well. In the US, drug cGMPs were formally introduced in 1963 and significantly rewritten in the 1970s. Canadian drug GMPs exist in various forms in the 1950s-1970s before being published in their current form in the 1980s.

- Y V Phani Raj, Hyderabad