Good Manufacturing Practice, or GMP, is a part of the quality system used in the manufacturing, testing and development of active pharmaceutical ingredients, products and medical devices. Regular and ongoing GMP training for those involved in the pharmaceutical industry is, therefore, of utmost importance.
Ensuring that Good Manufacturing Practice regulations are followed is referred to as GMP compliance. This is not necessarily simple because GMP guidelines change constantly to keep up with the industry. GMP training is an ongoing investment in personnel, products and the business itself.
From one country to another, GMP regulations can vary. Many countries have provided their own legislation regarding pharmaceutical and medical manufacturing. GMP training, then, has to cover the legislation of several countries at once.
The FDA is the US body responsible for enforcing GMP regulations. For this reason, GMP compliance and FDA compliance are generally considered to go hand-in-hand, and training agencies will cover both under the umbrella of GMP training.
More than 100 countries across the world use the World Health Organization’s version of GMP rules. The EU also has its own set of regulations. In the UK the Medicines Act (1968) governs the regulations.
Across the world, different regulatory authorities enforce GMP regulation inspections where medical devices and pharmaceuticals are manufactured. Any development and testing of new drugs must also follow GMP guidelines.
Companies who fail inspections can expect to face penalties. Fines and product bans are common but often most damaging is the loss of consumer confidence in the product. GMP training can ensure compliance and protect the interests of the company, its employees and its products.
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