Zimbabwe is working towards attaining the World Health Organisation (WHO) prequalification for the microbiology laboratory. This follows the refurbishment of the Medicines Control Authority of Zimbabwe (MCAZ) microbiology lab recently.
By Kuda Pembere
WHO states medicines prequalification primarily benefits populations requiring treatment for priority diseases, and women and girls in need of medicines to ensure their reproductive health.
This journey towards this prequalification comes at a time MCAZ celebrates its 25th anniversary.
In a statement, MCAZ Acting Director General Mr Richard Rukwata said they recently renovated their laboratory in line with the requirements to attain this prequalification.
The Authority is currently working on WHO Prequalification for the Microbiology laboratory following the laboratory’s recent refurbishment,” he said. “The Authority is also committed to meeting the requirements of the WHO Global Benchmarking Tool (GBT). This is a tool used for benchmarking regulatory systems across the globe. The GBT is designed to evaluate the overarching regulatory framework and the component regulatory functions.”
He also said they have since addressed gaps stalling them to achieve Maturity Level 3 of the GBT. “The Authority was initially assessed in August 2021 and is aiming to achieve Maturity Level 3 after addressing the identified gaps and formulating and implementing the Institutional Development Plan (IDP) issued following the August 2021 assessment and subsequent interactions with the WHO GBT assessment team,” said Mr Rukwata.
The MCAZ Acting Director General Mr Rukwata said among the milestone achievements attained in their 25 years of existence include ISO/IEC accreditation.
“In the 25 years of its existence, MCAZ has achieved several successes including the World Health Organization (WHO) pre-qualification of the Chemistry Laboratory and the ISO/IEC 17025:2017 accreditation of the laboratories by the Southern African Development Community Accreditation Services (SADCAS). MCAZ has also obtained the ISO/IEC 9001:2015 Quality Management Systems Requirements certification. What all this means is that medicines control testing at the MCAZ meets the best practice standards,” said he said.
The Authority has collaborated with various partners in implementing different projects and or programs.
“The partners include Global Fund, UNDP, UNICEF, WHO, SADC, EDCTP, and NEPAD just to name a few. These projects have recorded successes, some projects were completed, and some are still ongoing. For example, the ZaZiBoNa collaboration under the SADC Medicines Registration Harmonisation (SADC MRH) project is still ongoing.
“From inception MCAZ assumed a leading role in the collaborative medicine registration process between National Medicines Regulatory Authorities (NMRAs) of Zambia, Zimbabwe, Botswana and Namibia. This collaboration has since expanded to include the NMRAs of Comoros, the Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mozambique, Namibia, Seychelles, South Africa, Eswatini, Tanzania. MCAZ has another ongoing initiative of extending its testing services and regulatory training to other countries such as Burkina Faso, Tanzania, Ethiopia, South Sudan, Zambia, Lesotho, and Mauritius among others,” Mr Rukwata noted.
Mr Rukwata said they subscribe to the following international standards and guidelines to ensure compliance and maintenance of a solid regulatory system.
- ISO/IEC 17025:2017 standard for General Requirements for the Competence of Testing and Calibration laboratories
- ISO/IEC 17020:2012 standard for Conformity Assessment-Requirements for the Operation of Various Types of Bodies Performing Inspections
- ISO/IEC 9001:2015 standard for Quality Management System requirements
- Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL) for WHO Pre-Qualification
- WHO Global Benchmarking Tool
To ensure adherence to standards in the Inspectorate Unit, the Authority pursued accreditation to ISO 17020:2012 and in 2020, the Inspectorate Unit was accredited to ISO 17020 by SADCAS.
