What are the main elements of GMP?
What are the main elements of GMP?
Good Manufacturing Practices (GMPs) are a set of regulations designed to ensure that food, dietary supplements, cosmetics, pharmaceuticals, and medical devices are produced to the highest quality standards. The GMP regulations can be said to address five main elements of good manufacturing practices (also known as the 5 P’s).
- Products
- People
- Processes
- Procedures
- Premises
The 5 P’s are addressed through the implementation of the following general systems and controls:
Quality Management System (QMS)
A system for managing and controlling the quality of products, including procedures for documentation, validation, and testing. It helps to ensure that products are consistently produced to the highest quality standards.
Facility and Equipment Control
A system for controlling the design, construction, and maintenance of the manufacturing facilities and equipment to prevent or reduce the risk of contamination of products.
Production and Process Control
A system of strict controls to ensure that products are consistently produced to the highest quality standards, including guidelines for raw materials, intermediate products, and finished products.
Materials Management
A system for the procurement, storage, and handling of raw materials, intermediates, and finished products to ensure that they are of the correct quality and purity.
Laboratory Control
A system of controls for laboratory facilities to ensure that test results are accurate, reliable, and reproducible.
Packaging and Labeling Control
This program establishes guidelines for the design, production, and control of packaging and labeling to ensure that products are properly identified and that their safety and effectiveness are not compromised.
Complaint and Recall Handling
A system for dealing with complaints and the recall of products, including investigations, resolving complaints, and planning a recall if necessary.
Training
A system for training employees on GMP regulations and guidelines, and best practices, to ensure that they have the knowledge and skills necessary to comply with GMP regulations.
The above systems and controls are interrelated and work together to ensure that products are safe, effective, and of high quality, and that the company is in compliance with GMP regulations.
The implementation of a GMP program can be greatly aided with the help of a GMP consultant.
To learn of the specific processes that are required under GMP regulations, see What are the GMP requirements? List them all.
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