Quality Assurance

Last Updated on May 5, 2026

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
• Guidelines on Categorization of GMP Deficiencies

2. Quality

• Guidelines on Recalls of Defective Therapeutic Goods
• Guidelines for Storage and Destruction of Returned Therapeutic Goods
• Guidelines on Risk-Based Post-Marketing Quality Surveillance

3. Supply Chain

• Guidelines on Good Distribution Practices for Pharmaceutical and Biological Drug Product
• Guidelines on Good Cold Chain Management Practices for Time and Temperature-Sensitive Drug Products

4. Import and Export of Therapeutic Goods

• Guidelines on Import and Export of Therapeutic Goods
• User Manual / Guide for Online Import Export Software (OIES)