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Sierra Leone GMP Roadmap
Author:
WAHO
Category:
Good Manufacturing Practices and Inspections
Language:
English
Description:
Establishing pharmaceutical manufacturing at internationally recognised GMP standards
Abstract:
This is a national-level technical document. It is designed to outline an approach that allows the establishment of pharmaceutical manufacturers at internationally recognized standards of Good Manufacturing Practice (GMP), specifically WHO GMP. Sierra Leone does not currently have any active pharmaceutical manufacturers, hence the focus is providing guidance on how new facilities could be set up and operated according to these principles. This document has been developed as part of a regional project which encompasses a move to higher GMP standards for the pharmaceutical industry across ECOWAS. This regional work, known as the ECOWAS Regional GMP Roadmap Framework project, is designed to provide a technical basis for upgrading of pharmaceutical production standards that can be practically applied and presents a pragmatic approach to address the current heterogeneous situation within the pharmaceutical sector across West Africa. This national roadmap includes an introduction and summary of the Regional Framework project. It also provides a stepwise approach as a basis for the establishment of new manufacturers in Sierra Leone that are GMP compliant and hence are aligned with the framework that has been validated for the ECOWAS region.
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