Ensuring quality/GMP

GMP stands for Good Manufacturing Practice which means having procedures in place to ensure that products are prepared in a clean environment and that the products do not become contaminated in production.  Microbial contamination can be quite common as many micro-organisms live freely in the atmosphere around us.  Contamination of products can lead to degradation and, in severe cases, could cause harm to the consumer.  To a certain extent, GMP can also help protect the manufacturers themselves from the manufacturing process.  The CTPA has a GMP guidance document available to purchase.  The cost is £90 for non-members.  See our 'guidance for industry' section.

CTPA is aware there is some misinterpretation of the GMP requirements, especially under the new Regulation, and in particular that the relatively new ISO standard for GMP, 22716, will become a legal requirement.  This is not the case.  You will be presumed to be compliant with the Regulation if you use the ISO GMP guideline, but you don’t have to.  Companies are free to use whatever GMP they wish, they would though be required to demonstrate their own system achieved the same objective as that of the ISO GMP guideline.