Gap Assessment of Zimbabwean Pharmaceutical Industry for UNIDO

• The assessment of eight pharmaceutical GMP plants in Zimbabwe against the 17 key WHO GMP elements. As well as any additional key metrics that PCS may deem of importance. The ensuing observations were classified according to EMA/385898/2013 Rev 16.
• A report was drawn up for each manufacturer utilizing the 17 key WHO GMP elements and each GMP manufacturers’ score against these 17 WHO GMP key elements.
• Two levels of cost estimations were produced that covered upgrading each GMP facility to WHO-GMP standards. These estimations included the utilities, facilities, equipment and QMS of each individual plant. Also, the cost of rectifying all critical deficiencies was provided.
• A summary report of the overall findings were presented to all stakeholders.
• A meeting in Zimbabwe with officials and others was held separately after finalization of the assessments and cost-estimations.
• A project preparation meeting at the Bronte Hotel in Harare.

1. Pharmaceutical quality system
2. Good manufacturing practices for pharmaceutical products
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production, analysis, and other activities
8. Self-inspection, quality audits and suppliers’ audits and approvals
9. Personnel
10. Training
11. Personal hygiene
12. Premises
13. Equipment
14. Materials
15. Documentation
16. Good practices in production
17. Good practices in quality control

A: Existing approach towards pharmaceutical manufacturing in general in line with WHO GMP requirements à low-risk company

B: Existing approach towards pharmaceutical manufacturing not in line with WHO GMP, but reduced risk with regard to production safety à medium risk company

C: Existing approach towards pharmaceutical manufacturing not in line with WHO GMP, and high risk with regard to production safety à high-risk company