GMP provides the assurance of proper design, monitoring and control of manufacturing processes and facilities.
Identity, Strength, Quality, & Purity
Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
This includes, but is not limited to, establishing a strong quality management system, obtaining quality raw material, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining reliable testing laboratories.
Flexibility in the Regulations
This formal system of controls established in a pharmaceutical company helps to prevent instances of contamination, mix-ups, deviations, failures and errors.
This helps to assures that drug products meet their quality standards.
The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve quality through continual improvement.
Apart from the direct manufacturing process GMP applies to all of the indirect activities of manufacturing medicinal products including, but not limited to:
1. The Quality Management System (QMS)
3. Premises & Equipment
4. Qualification & Validation
5. Good Practices in Production
6. Good Practices in Quality Control
7. Complaints & Recalls
9. Change Control
11. Supplier Oversight
12. Quality Control Laboratories