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Joint Audits
An exchange of knowledge and experience among players of the medicines supply chain is vital to improving the quality of medicines. A joint audit, where Drug Supply Organizations (DSOs) and manufacturers are brought together, is one such instance. In addition to improving the quality of the manufacturing process, a joint audit reduces the costs involved with inspections and improves the quality of audits.
action medeor has been carrying out regular audits of pharmaceutical manufacturers in East Africa as part of Quality Assurance of medicines in its branches in Tanzania and Malawi. Overall, 15 audits of 10 manufacturers have been conducted in the previous years. External expert/s or consultant/s are appointed to conduct the audits together with an action medeor pharmacist. These are also often accompanied by trainings on Good Manufacturing Practices (GMP)-related topics.
In the months of May and June 2014, joint audits of 6 manufacturers were carried out - 4 in Kenya and 2 in Uganda. Four of the manufacturers produce solid and liquid dosage forms, while two are mainly involved in sterile manufacturing. The results of the joint audits show encouraging improvements in the GMP standards of the manufacturers in East Africa. All 6 manufacturers have been approved as ‘qualified manufacturers’ for action medeor Tanzania and Malawi. A high level of satisfaction was expressed from the part of the manufacturers, who indicated that they were able to have a hands-on experience from an expert, which they were not able to receive anytime during their studies.
action medeor will continue to plan such audits with the aim of qualifying more manufacturers for its branches. For the year 2015, a joint audit of action medeor Germany, Tanzania and Malawi is being planned of two manufacturers located in Tanzania.