Abstract:
Background: Pharmaceutical Quality System is the sum of all aspects of a system that implements
quality policy and ensures that quality objectives are met as per aspiration of stakeholders throu
ghout the pharmaceutical operations, manufacturing as well as distribution. Maintaining quality
in medicinal products is a complicate procedure that requires pharmaceutical manufacturing
companies to follow numerous rules such as GMP, GLP, and others. As a result, evaluating the
implementation of a quality system is critical to maintaining the continual development of high-
quality products, as well as public safety and health.
Objectives: To evaluate and compare quality systems implementation in selected pharmaceutical
manufacturing companies in Ethiopia.
Methodology: The study was conducted with comparative cross-sectional descriptive study design
by comprehending of data from self-administered questionnaire, field observation checklist and
semi structured interview guide questions. Both qualitative and quantitative method were used. F
ield observation was conducted using structured checklist adopted from WHO GMP guideline. The
study included six pharmaceutical manufacturing companies (three from EFDA GMP certified
and three from non-certified). Key respondents were purposively selected on the basis of
responsibilities they have and the role they played in the subject matter of this study.
Result: the study revealed that the premises, production, equipment and HVAC system were
adequate for implementing quality system in company1, 2 and 3. The implementation of key GMP
quality elements were good in company1, 2 and 3. The compliance rate of quality system guides
were found to be 93.3% in both company 1 and 2. While 75.3% in company 5. The critical
deficiency was observed in company 4, 5 and 6.
Conclusion: From a list of Ethiopian pharmaceutical manufacturing companies that have been
assessed according to WHO GMP guidelines. The implementation status of quality system regards
the key WHO GMP quality element was good and higher compliance rate of GMP in EFDA GMP
certified companies than non EFDA GMP certified companies. As a result, non EFDA GMP
certified companies should upgrade their manufacturing facilities and concentrate on closing the
gaps that have been discovered. The EFDA should be closely monitored and followed up the GMP
status of pharmaceutical manufacturing companies
