Feasibility of an official medicines control laboratory

Abstract

Official Medicines Control Laboratories (OMCLs) are public organisations that work independently from the pharmaceutical industry to assure the quality of medicines and protect public health. OMCLs form part of a General European OMCL Network (GEON) which encompasses European and International OMCLs. Malta subcontracts the post market surveillance of medicinal products on its market from European OMCLs. The aim of this research was to determine the function of OMCLs with special reference to the present European scenario with emphasis on the rationale and sustainability of establishing an OMCL in a small member state. The study comprised three phases. Phase I focused on literature review to determine the characteristics and functions of OMCLs. Phase II identified the technical and scientific attributes through site visits to laboratories of Good Manufacturing Practice certified manufacturers established in Malta and visits at European OMCLs. Gaps which an OMCL with an innovative scope could address were identified through a focus group discussion and a validated ‘Gap Analysis Questionnaire for Public Laboratories in Malta’ targeting governmental public testing laboratories in Malta during Phase III of the research. Study findings from the literature review in Phase 1 resulted in 46 articles for the search term Official Medicines Control Laboratories with eight articles focused on vaccine testing as the main theme. The search term General OMCL Network yielded 24 articles with the most popular themes being articles each focusing on nitrosamine testing (n=5), vaccines (n=5) and parenteral products (n=5). Phase II highlighted issues such as lack of availability of technical staff. Results obtained in Phase III indicate the importance of project management in the establishment of the local OMCL and technical staffing issues. Gaps identified through the ‘Gap Analysis Questionnaire for Public Laboratories in Malta’ include lack of expertise and availability of technical staff, financial resources and accreditation processes. The research attempts to put forward recommendations for the establishment of an OMCL in small member state such as Malta. The research looks at state of the art design of an OMCL incorporating innovative aspects such as increased collaborative testing for other local or foreign public laboratories thereby maximising the use of technical capacity and equipment, enhancing its sustainability and feasibility whilst also providing a platform for training to local and foreign scientific personnel.