Quality Assurance

Last Updated on March 1, 2024

Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the Quality Assurance and Import/Export of therapeutic goods. DRAP in collaboration with the Drug Control Organization of all federating units is enforcing the implementation and has regulatory oversight to ensure that the drug products being manufactured, imported, distributed, and sold, meet quality requirements and applicable regulations.

1. Manufacturing

Guidelines on Good Manufacturing Practices
English ( 524 KB – PDF)

Guidelines on Categorization of GMP Deficiencies
English ( 1.4 MB – PDF)

2. Quality

Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods
English ( 658 KB – PDF)

Guidelines for Storage and Destruction of Returned Therapeutic Goods

English ( 587 KB – PDF)

3. Supply Chain

Guidelines on Good Distribution Practices for Pharmaceutical and Biological Drug Product
English ( 680 KB – PDF)

Guidelines on Good Cold Chain Management Practices for Time and Temperature- Sensitive Drug Products
English ( 902 KB – PDF)

4. Import and Export of Therapeutic Goods

Guidelines on Import and Export of Therapeutic Goods
English ( 609 KB – PDF)

User Manual / Guide for Online Import Export Software (OIES)
English ( 724 KB – PDF)