GMP is the abbreviation for Good Manufacturing Practice and refers to a set of regulations and guidelines for the manufacturing of pharmaceutical products. These regulations ensure that products are consistently produced and controlled according to quality standards, minimising the risks involved in pharmaceutical production that cannot be eliminated through testing the final product. In the UK and across Europe, you may see GMP referenced as EU GMP.

EU GMP guidelines cover all aspects of production, from the raw materials used in production to facilities, equipment and staff involved in manufacture. GMP includes the processes of manufacturing, packaging and testing, ensuring that the products are safe and meet the required quality standards.

The European Medicines Agency (EMA) provides guidance for EU GMP and individual country’s regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, are responsible for the licensing of both pharmaceutical products and the facilities where they are manufactured.

The MHRA specifies that GMP is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:

• Be of consistent high quality
• Be appropriate to their intended use
• Meet the requirements of the Marketing Authorisation (MA) or product specification

Key elements of EU GMP include:

• Pharmaceutical Quality System (PQS)
• Premises
• Equipment
• Utilities
• Personnel
• Production
• Monitoring
• Quality Control (QC)