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.
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:
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.
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).
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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