FACT WIKI · Concept
Good manufacturing practice for medicines
Good manufacturing practice for medicines
Good manufacturing practice (GMP) is a system for ensuring that medicines are consistently produced and controlled according to quality standards.
Roles and functions
GMP is designed to minimize production risks that testing the finished medicine cannot eliminate. WHO identifies unexpected contamination, incorrect container labels and too little or too much active ingredient among these risks.
How it works
In its explanation of United States current good manufacturing practice (CGMP), FDA says testing alone cannot ensure quality because it generally examines only a small sample of a batch. Quality must also be built into manufacturing through maintained and calibrated equipment, trained employees and reliable, reproducible processes.
In the United States framework, the 'current' in CGMP requires manufacturers to use up-to-date technologies and systems. FDA describes the requirements as flexible enough for manufacturers to choose scientifically sound designs, processing methods and testing procedures for implementing the necessary controls.
Processes that could affect a finished medicine's quality require detailed written procedures. GMP also requires systems that document whether the correct procedures were consistently followed at each manufacturing step whenever a product was made.
Scope and limitations
WHO has established detailed GMP guidelines. Many countries have developed their own requirements based on WHO GMP, while others have harmonized requirements through arrangements such as ASEAN, the European Union and the Pharmaceutical Inspection Convention.
GMP covers all aspects of medicine production, including starting materials, premises, equipment, staff training and personal hygiene. Its scope therefore extends throughout production rather than being confined to the finished product.
Background and related concepts
Under the United States framework described by FDA, a drug made without compliance with CGMP is legally considered 'adulterated.' That classification concerns the manufacturing conditions and does not necessarily mean that the drug itself has a defect.
References
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