Good manufacturing practice
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Pronunciation
Good Manufacturing Practice: /ɡʊd/ /ˌmanjʊˈfæktʃərɪŋ/ /ˈpræktɪs/
Etymology
The term "Good Manufacturing Practice" is derived from the need to establish specific best practices in the manufacturing industry to ensure product quality and safety.
Related Terms
- Quality Control: A process by which entities review the quality of all factors involved in production.
- Quality Assurance: A way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers.
- Regulatory Compliance: An organization's adherence to laws, regulations, guidelines and specifications relevant to its business processes.
- Standard Operating Procedure: A set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations.
History
The concept of GMP was first introduced in the United States in the 1960s. The Food and Drug Administration (FDA) developed regulations that manufacturers of food, drugs, medical devices, and blood products had to follow to ensure their products were safe and effective. These regulations were later adopted by other countries and have since become the international standard for pharmaceutical manufacturing.
Importance
GMP is important as it ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use. It is designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product.
Implementation
Implementing GMP involves establishing systems that ensure products are produced and controlled according to the quality standards. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
See Also
External links
- Medical encyclopedia article on Good manufacturing practice
- Wikipedia's article - Good manufacturing practice
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