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Gap Assessment of Zimbabwean Pharmaceutical Industry for UNIDO
PCS performed a WHO GMP gap assessment of the Zimbabwean pharmaceutical industry for UNIDO.
WHO GMP gap assessment for nine days at Yuxi Wlvax China, helping Walvax prepare for a WHO prequalification audit.
Performing gap assessments of eight manufacturers in Zimbabwe as part of a United Nations intervention in South Africa, including costing-estimations to upgrade manufacturers to WHO GMP standards
As a part of UNIDO’s mission to increase the capacity of the local pharmaceutical sector in developing countries to supply safe, efficacious and affordable medicines PCS was asked to perform a WHO GMP gap assessment of the Zimbabwean pharmaceutical industry.
PCS was asked to perform a number of activities for this assignment:
- 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.
Upon conclusion of the gap-assessment of the Zimbabwean pharmaceutical organizations a meeting was held in South Africa to present the findings, cost estimations and the overall score of the pharmaceutical manufacturers against the WHO GMP.
WHO's 17-key GMP elements
The assessment reports were based on the seventeen (17) essential quality elements of WHO GMP as described in Annex 2 (1) of TRS 986, 2014 (2).
- Pharmaceutical quality system
- Good manufacturing practices for pharmaceutical products
- Sanitation and hygiene
- Qualification and validation
- Product recalls
- Contract production, analysis, and other activities
- Self-inspection, quality audits and suppliers’ audits and approvals
- Personal hygiene
- Good practices in production
- Good practices in quality control
Using the WHO’s 17 key GMP elements, each manufacturer could then be scored, the score was input into a matrix to determine the compliance status.
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
For each of the manufacturers, a cost estimation was developed to help them understanding the investment required to upgrade their facilities and quality system to the latest WHO GMP requirements.
The cost estimations included factors such as; facility, equipment, quality management system, utilities, personnel qualification and possible external consultancy costs to help the manufacturers in their efforts.
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