DOI

10.5703/1288284317576

Tech Report Number

TR-BIRSAFRICA-2022-2

Date of this Version

9-2022

Keywords

Good distribution practice (GDP), inspection, assessment tool, training, regulatory agency

Abstract

Good Distribution Practice (GDP) refers to the regulatory guidelines governing the wholesale and distribution of medicinal products to ensure that their quality and integrity are maintained throughout the supply chain from the manufacturer to the end users. A standard assessment tool for GDP is necessary in order to conduct a robust assessment on GDP on pharmaceutical industries. The observed agency’s policy and operational documents in addition to GDP Guidelines from World Health Organization and related organizations from various countries were reviewed. The observed Regulatory Agency does not have a separate assessment tool for GDP inspection. Few core GDP parameters are captured in a section of the GMP reporting format. The included parameters addressed the activities in the production areas and do not address the major distribution activities and processes. Thus, it is unlikely that a robust inspection will be carried out in the absence of a separate GDP assessment tool. There is need for a separate and robust GDP assessment tool, training of inspectors in line with the tool and a separate GDP inspection, outside the GMP inspection, Majority of the GDP guidelines reviewed from various countries were in line with the World Health Organization’s GDP guideline. Based on the findings, an Assessment Tool for Good Distribution Practice was developed for the agency, to be applied to all distributors, coordinated wholesale centres, wholesalers and retailers. There is need for the agency to adopt the Assessment Tool, develop its own guidelines for GDP and train all pharmaceutical inspectors on uniform assessment and interpretation of indices, reporting of observations and conclusions.

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