Good Practices Compliances (GxP)

Last Updated on February 23, 2022

The Quality Assurance and Laboratory Testing Division is responsible for enforcement of current Good Manufacturing Practices under the DRAP Act 2012. Federal Inspectors of Drugs are notified under Section 17 of Drugs Act 1976 and schedule V of DRAP Act 2012 are responsible for monitoring compliance to the current Good Manufacturing Practices by the manufacturers and conducting post marketing surveillance activities including inspections of manufacturing facilities in their respective jurisdiction according to prescribed procedures. Similarly, Provincial Government also appoints provincial inspectors of drugs for conductions of inspections in their respective jurisdiction related to sale, storage and distribution of drugs.

Current Good Manufacturing Practices

Schedule B, Schedule B-I and Schedule B-II (GMP) of The Drugs (Licensing, Registering and Advertising) Rules, 1976 provides comprehensive guidelines covering Good Manufacturing Practices for all processes involved in the manufacturing of medicinal products including biologicals and vaccines which are mandatory to be followed by all manufacturers and market authorization holders. DRAP is also phase wise adopting Pharmaceutical Inspection Cooperation Scheme (PIC/S) guidelines on Good Manufacturing Practices.

Risk-Based Inspection to Monitor cGMP Compliances

DRAP has adopted risk based method for prioritizing cGMP inspections of the manufacturing units, on the basis of their over all risk ranking against a well-defined analytical processes for risk assessment, to enhances the quality of inspection program and transparency. The manufacturing units licensed or enlisted under the DRAP Act 2012 and the Drugs Act 1976 are inspected by the GMP Inspection panel with a frequency depending upon manufacturers risk-based rating.