GOOD MANUFACTURING PRACTICES (GMP)
What is Good Manufacturing Practices ?
Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of the selected product. It serves as a basic foundation program in manufacturing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product.
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.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix ups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
An effective implementation of GMP can addresses issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
GMP covers quality assurance programs and organization, buildings, equipment, components, production and process controls, packaging and label control, distribution and installation, device evaluation and records.
Benefit Of Good Manufacturing Practices
Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of the selected product. It serves as a basic foundation program in manufacturing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product.
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.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix ups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
An effective implementation of GMP can addresses issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
GMP covers quality assurance programs and organization, buildings, equipment, components, production and process controls, packaging and label control, distribution and installation, device evaluation and records.
Benefit Of Good Manufacturing Practices
- Ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by the product specification.
- Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers
- A system is available for recalling any batch of products from sale or supply.
- Increases senior management confidence in the preparedness of manufacturing facilities for FDA inspection
- Demonstrates independent third-party verification of continuing conformance to GMPs