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GMP - Good Manufacturing Practice Regulations

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A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products.

Benefits of the GMP Registration Program

  • Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers.
  • Increases senior management confidence in the preparedness of manufacturing facilities.
  • Manufacturing processes are clearly defined and controlled.
  • Demonstrates independent third-party verification of continuing conformance to GMPs.

 

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.