GMP, or Good Manufacturing Practice is part of a system of quality assurance which covers the manufacture and testing of active pharmaceutical ingredients, pharmaceutical products and medical devices. It is therefore important to provide ongoing GMP training for employees in the pharmaceutical sector.
Following the rules and guidance of Good Manufacturing Practice is known as GMP compliance. This is not necessarily simple because GMP guidelines change constantly to keep up with the industry. GMP training is therefore most certainly not a one off. Rather it must be considered an ongoing investment in the employees, the products and the entire company.
The GMP regulations of each country vary. Many countries have created their own legislation for pharmaceutical and medical device companies to follow. GMP training must cover all the relevant countries.
The FDA is the US body responsible for enforcing GMP regulations. This is why GMP compliance and FDA compliance are often thought of as one and the same and the GMP training provided by most pharmaceutical training agencies will cover FDA compliance within GMP training.
There is a World Health Organisation of GMP rules, used by over 100 countries. Similarly, the European Union uses its own set of regulations. In the UK the Medicines Act (1968) governs the regulations.
Across the world different regulatory authorities enforce GMP regulations. It is common for premises in which devices and medications are manufactured to be inspected to ensure they meet regulations. Any development and testing of new drugs must also follow GMP guidelines.
In the event of a company failing to comply to GMP rules, there can be serious penalties. Fines and having products banned from the market can happen, but loss of consumer trust is perhaps most damaging. When provided by a respected agency, GMP training ensures compliance and protects the business, its staff and its products.
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