Inspection Report Harmonization Boosts Regulatory Oversight at DRAP

The Drug Regulatory Authority of Pakistan (DRAP) has taken major steps to strengthen its regulatory oversight by introducing a single, harmonized format for inspection reports. This new initiative aims to enhance consistency, transparency, and credibility in the documentation of pharmaceutical inspections across the country.
In a recent training session organized by the Division of Quality Assurance & Laboratory Testing, DRAP introduced the new uniform inspection report format to its field force and Good Manufacturing Practice (GMP) auditors. The training focused on effective report writing and familiarizing the team with the latest standardized procedures.
Previously, inspection reports were prepared using various formats depending on the region and officer, which often led to inconsistencies and reporting gaps. To address these challenges, DRAP has developed a harmonized template that ensures all inspections follow the same internationally recognized standards.
This move is expected to improve the reliability and accuracy of inspection reports, bolster regulatory compliance, and further Pakistan’s efforts toward achieving the World Health Organization’s Global Benchmarking Tool maturity goals. Through these reforms, DRAP emphasizes its ongoing commitment to maintaining a robust regulatory framework that protects the quality, safety, and efficacy of medicines available to the public.



