The Division of Quality Assurance & Laboratory Testing at the Drug Regulatory Authority of Pakistan (DRAP) has launched a comprehensive effort to standardize its inspection reporting processes. By introducing a uniform inspection report format and conducting specialized training for its field staff and Good Manufacturing Practice (GMP) auditors, DRAP aims to enhance consistency, transparency, and compliance in its regulatory operations.
Historically, DRAP inspectors used various formats for their reports, which led to inconsistencies and occasional gaps in documentation across different regions. The absence of a unified system sometimes undermined the accuracy and reliability of regulatory oversight. To address this, the authority has developed a harmonized report template, ensuring that all inspections are recorded in a standardized way, in line with international practices.
The new standardized approach is expected to improve the credibility and precision of inspection records, strengthen regulatory compliance, and boost overall oversight of pharmaceutical manufacturing within Pakistan. Moreover, this initiative supports the country’s ongoing efforts to meet the World Health Organization’s Global Benchmarking Tool requirements, an important step towards achieving higher maturity levels in national regulatory systems.
Through these reforms, DRAP reiterates its commitment to building a rigorous regulatory framework that protects public health by ensuring the safety, quality, and effectiveness of medicines available in Pakistan.
