Good Manufacturing Practice

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. In medicines, it covers both production and quality control: suitable materials and premises, trained staff, clearly defined processes and records that show how each batch was made. GMP is not a single worldwide certificate: many countries have formulated their own GMP requirements based on those of the World Health Organization (WHO), and others have harmonised their requirements, for example in the European Union.

How manufacturing controls work

Testing the finished product examines only a small sample of a batch, and it cannot catch every error in every unit. Controls throughout production help prevent contamination, incorrect labels and too little or too much of the active ingredient. Written procedures set out how each step is done; trained staff, hygiene, properly maintained equipment and reliable, reproducible processes are further elements of the controls. Good quality therefore has to be built in during manufacture; it cannot be tested into the product afterwards.

The WHO principles of GMP for pharmaceutical products require manufacturing processes to be clearly defined and systematically reviewed, qualification and validation to be performed, and significant deviations to be recorded and investigated. Records of manufacture and distribution allow the complete history of a batch to be traced. There must be a system to recall any batch from sale, and complaints about marketed products are examined and the causes of quality defects investigated.

Requirements by sector

The requirements depend on the kind of product: specific GMP requirements for classes of products, such as sterile or biological medicines, are set out in annexes to the general requirements. The first WHO draft text on GMP was adopted in 1968; in 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the quality of pharmaceutical products moving in the global market, it accepted WHO GMP as an integral part of the scheme.

In the United States, the Food and Drug Administration (FDA) uses the term current good manufacturing practice (CGMP): "current" means that companies must apply up-to-date technologies and systems to comply with the regulations.

Cosmetics have their own GMP standard. The European Commission's list of harmonised standards for cosmetic products includes EN ISO 22716:2007, Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices.

Inspections and certificates

Any manufacturer of medicines for the European Union market must comply with EU GMP, wherever in the world it is located. The European Medicines Agency (EMA) coordinates inspections to verify compliance. After inspecting a manufacturing site, the competent authorities issue a GMP certificate or a non-compliance statement, which is entered in EudraGMDP, a publicly accessible EU database.

Inspecting manufacture is not the same as approving a product. For example, the FDA periodically inspects dietary supplement manufacturing facilities to verify that companies meet the applicable manufacturing and labelling requirements, but it does not have the authority to approve dietary supplements for safety and effectiveness before they are sold.