Human Medicines Inspection

 

The Pharmaceutical Inspection and Licensing Division is responsible for:

 

1. Conducting inspections of pharmaceutical establishments to verify compliance with applicable laws, regulations, Good Practice (GxP) standards and Quality Management System (QMS). 

2. Conducting Good Clinical Practice (GCP) inspections to verify compliance with approved protocols, regulatory requirements, and international standards. 

3. Assessing the suitability and operational readiness of regulated premises, including infrastructure, equipment, utilities, sanitation, hygiene, and personnel, to ensure compliance with regulatory requirements. 

4. Granting, renewing, suspending, or revoking licenses and issued GxP certificates and certificates of compliance to quality audits for pharmaceutical establishments based on inspection findings and compliance status. 

5. Providing regulatory guidance and technical recommendations to facilitate corrective and preventive actions (CAPA) and promote sustained regulatory compliance. 

6. Collaborating with national, regional, and international regulatory authorities to strengthen regulatory harmonization, information exchange, and adoption of best regulatory practices.