TANZANIA has registered yet another milestone after the Muhimbili University of Health and Allied Sciences (MUHAS) pharmaceutical research and development laboratory became the first in Africa to attain ISO accreditation as a proficiency testing provider on solid dosage forms.
This follows the successful implementation of the regional capacity building programme for proficiency testing services in the pharmaceutical sector by the East African Community (EAC) secretariat in cooperation with the Germany Metrology Institute (PTB).
Pharmaceutical Research and Development (Pharm R&D), Lab Manager, Prof Eliangiringa Kaale, told the ‘Daily News’ that the accreditation attained in July 2020 translates into more trust and satisfaction to pharmaceutical testing laboratories customers in the region.
“Provision of proficiency testing in the pharmaceutical area is critical; we are glad to be the only lab in Africa to attain accreditation according to the requirements of ISO/IEC 17043. So far, we have undertaken nine regional proficiency tests on solid dosage forms,” he said.
The served clients are from Tanzania, Kenya, Uganda, Rwanda, Burundi, Eretria, Seychelles, Congo DRC and Ethiopia.
Others are Quality Control labs from National Medicines Regulatory Authority (NMRA), National Bureau of Standards (NBS), industries and procurement agents.
Prof Kaale said the accreditation means that one has been tested by a certified organization to prove that the services are offered with the highest acceptable standards.
“ISO has national standard bodies in various countries but in Tanzania, we still do not have one; so we are relying on Kenya and Southern African Development Community Accreditation Services (SADCAS),” he noted.
The lab manager further said that they commenced providing such services in 2011 but before attaining accreditation from Kenya Accreditation Service (KENAS), they underwent various training sessions and inspections were conducted until they qualified.
He further said that they manufacture and conduct quality testing but to do the testing, they must meet certain standards that must be measured by a third party.
So Pharm R&D’s role is to conduct proficiency testing in those industries but for them to perform that role properly, they must also be tested and accredited.
The don revealed that plans were underway to expand their services to the whole of Africa, as well as to approach the World Health Organization (WHO) and request them to use the MUHAS lab for the samples within Africa since it’s much easier and cost-effective.
Pharm R&D Lab is integrated into the MUHAS School of Pharmacy; it has two units; Pharmaceutical Technology Laboratory (PTL) and Pharmaceutical Analytical laboratory (PAL).
PTL is a current Good Manufacturing Practice (CGMP) model equipped lab involved in research on formulation development, including solid dosage forms like tablets and capsules.
PAL is an analytical testing lab involved in quality assurance and quality control of medicines like analytical testing, post-marketing surveillance testing, analytical method development and validation, stability studies of finished products.
According to him, the lab also provides training, R&D and consultancy services in the pharmaceutical sector within East Africa.
It has gained experience in proficiency testing through various training and participation in WHO external Quality Assurance testing schemes.
Expounding further, he said the accreditation is valid for five years and each year KENAS will be conducting an annual inspection to see if they still meet the criteria.