GMP Training To Ensure Compliance
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. Because the pharmaceutical and medical device industries are so constantly evolving, GMP guidelines are ever changing. GMP training is not to be considered a one off. Rather it is an ongoing investment in personnel, products and the business itself.
From one country to another GMP regulations can vary. A large amount of countries have created their own legislation for pharmaceutical and medical companies to follow. GMP training must cover all the relevant countries.
In the US it is the FDA which enforces the 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.
The World Health Organisation also has its own version of GMP rules which are used by the regulators of more than 100 countries worldwide. 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. Inspections of places where medical devices and medications are manufactured are frequent to ensure that stringent safety rules are met. New medications must also be developed and tested within 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. When provided by a respected agency, GMP training ensures compliance and protects the business, its staff and its products.
