Course Code: ELM-103-09

The Good Manufacturing Practice Concept: Pharmaceutical Industry [Video]

GMP provides the assurance of proper design, monitoring and control of manufacturing processes and facilities.

Assuring Drugs Meet Standards

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.

Formal System of Controls

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.

Flexibility for Technology and Innovation

The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve quality through continual improvement.

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering