Manufacturing drugs for human use is a complicated process frequently involving compounds and materials that, if used incorrectly, can be hazardous to people’s health. Highly regulated nations (such as the US, EU, Australia and Canada) have long realised the necessity that they develop strict guidelines governing these processes to protect patients and ensure product safety, quality and efficacy. Poor quality drugs, manufacturing processes or conditions can have extreme and dire consequences for patients. In countries that enforce Good Manufacturing Practice (GMP) the penalties for non-adherence reflect its importance and can include forcing worldwide product recalls, seizure of property, large fines, even imprisonment.
GMP includes a set of principles and procedures that drug manufacturers must follow in order to ensure that their products are safe, pure and effective. These principles are incredibly thorough, but also flexible and open-ended, including a requirement that manufacturers remain up to date with technology and policy developments. This ensures manufacturers are working constantly to stay up to date and maintain their GMP compliance.
A central tenet of GMP is that “quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process”. In other words, GMP makes certain that a product is of high quality by ensuring that all ingredients, technology, equipment, buildings, technicians, professionals, and processes used to create it are capable of consistently delivering and maintaining a high level of quality.
In terms of GMP, manufacture refers to any part of the process that produces the drug or is involved in creating the drug product delivered to the consumer or medical professional. This includes processing, assembling, packaging, testing, labeling, storage and sterilising and release for supply, as well as machinery, ingredients and any other materials that form any part of the process or the end product itself.
The risks to the general population imposed by poorly regulated or manufactured drugs make the need for global adoption and adherence to GMP of paramount importance.
In Australia, the Therapeutic Goods Administration (TGA) requires that drug manufacturers obtain a license and be open to audits assessing their processes and practices. If an overseas company is supplying drugs for use in Australia, they are held to the same strict standards as the local manufacturers and must also make themselves available for audits of the same depth and breadth.
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Source: National Cancer Institute
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