Quality risk management implementation for a medicinal products wholesale dealer

Abstract

OBJECTIVES: The aims of this study were to compile a model of a Quality Management System (QMS ) for distribution of medicines, identify the risks in distribution to the quality of medicinal products from a Maltese wholesale dealer’s perspective and evaluate these risks using Quality Risk Management (QRM) methodology. The ultimate objective was to indicate whether risks are being well managed and to propose appropriate corrective and preventive actions (CAPA). METHOD: A set of model Standard Operating Procedures (SOPs) which describe the current wholesale dealer’s operations was compiled. These SOPs were written in simple English to facilitate comprehensiveness by the employees. The various steps in the distribution of medicinal products by a wholesaler and the risks in each step were identified and a flowchart was compiled. A QRM assessment was carried out, taking into consideration current risk management activities described in SOPs. No further action was recommended for risks which were deemed as acceptable, however appropriate CAPA was recommended for risks deemed as being unacceptable. KEY FINDINGS: Out of 70 identified risks during QRM evaluation, 65 risks were deemed acceptable, while 5 were deemed not acceptable. Areas exhibiting unacceptable risks were ‘Returns of medicinal products’ (1 risk) and ‘Temperature monitoring and control during shipment from supplier’ (4 risks). CONCLUSION: CAPA was proposed to change the profile of unacceptable risks. A model QRM SOP was compiled to be used by Maltese wholesale dealers in setting up a QRM system and to help in fulfilling regulatory obligations.