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Compendium of Good Manufacturing Practices (GMP) Technical Documents for Harmonization of Medicines Regulation in The East African Community

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Compendium of Good Manufacturing Practices (GMP) Technical Documents for Harmonization of Medicines Regulation in The East African Community

The EAC-MRH Programme was established to improve public health through harmonization of medicines regulation and all matters
related to improved access to medicines of acceptable quality, efficacy and safety in the EAC region.

Regulation of medicinal products involves among other things, inspection of pharmaceutical plants to verify compliance to GMP. GMP is that part of quality assurance which ensures that products are consistently produced and controlled to meet quality standards appropriate for the intended use and as required by marketing authorization. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP inspections are conducted as one of the requirements for registration of medicinal products in the EAC. Such inspections are also conducted for operating as well as
new pharmaceutical plants so as to verify compliance with GMP standards. Inspection involves review of documents, records, facilities and any other resources to assess their conformity to the requirements of EAC GMP of medicinal products.

Consistency in conducting GMP inspection activities is very important in ensuring quality assurance of pharmaceuticals by the NMRA. This results into common decision making by different EAC GMP inspectors at the end of inspections and thus avoiding complaints from manufacturers.

In order to achieve that goal, EAC GMP inspectors need to be provided with this Manual which contains sufficient working
tools needed for observing, investigating and reaching conclusions in a particular inspection.

The Manual highlights general conditions
and other pertinent requirements that are necessary for carrying out GMP inspections.
It is divided into various sections which amongst other things outline different types
of inspections, qualifications, training and experience required for inspectors as well as code of ethics and conduct to be observed
by inspectors when engaged in inspection activities. Moreover, the Manual defines procedures to be followed when preparing and planning for inspection, reporting requirements including format and classification system adopted for non-compliances observed during GMP inspection.

Various working documents are also referred to in this Manual to help inspectors to comprehend matters related to GMP. It is also expected that the Manual shall help inspectors to conduct GMP inspection with integrity and diligence.

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GMP_Compendium_FINAL_2014.pdfDownload

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