Good Manufacturing Practice or GMP (also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.

Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).

In the US, the phrase “current good manufacturing practice” appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.

The workflow can be simplified as follows:

GMP requires that all manufacturing and testing equipment has been qualified as suitable for use

• in use for testing and making its suppositoria

• as well as our other collections, from the balance weight

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