Journal of Developing Drugs
Open Access

Good manufacturing practices: The gap within (developing countries)

Joint Event on 8^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR & 8^th International Conference and Exhibition on Pharma Audit, GMP, GCP & Quality Control

June 08-09, 2018 | Philadelphia, USA

Bernice Brempong

Makhealth Pharmaceuticals Ltd., Ghana

Scientific Tracks Abstracts: J Develop Drugs

Abstract :

Good Manufacturing Practice (GMP) is part of the quality management system which ensures that products are consistently produced and controlled to meet quality standards appropriate for their intended use as required by the marketing authorization, clinical trials authorization or product specification. Current Good Manufacturing practice (cGMP) is aimed at managing and minimizing the risks inherent in pharmaceutical manufacturing to ensure that the quality, safety and efficacy of products are reproducible. Such risks are essentially human errors which occur during the handling and processing of materials and machines. While most pharmaceutical industries from the industrialized world work tirelessly to comply with cGMP requirements to produce in compliant facilities, industries in the developing countries have not been able to meet most of these requirements. Factors such as lack of skilled personnel with technical know-how, weak regulatory systems, lack of appropriate equipment, machinery and technology and high cost of manufacturing drugs thus modern equipment and technology among others have been identified as some of the major factors within the sector bringing about the differences we see today in developing countries. In conclusion, GMP guidelines provide the requirements that a manufacturer must meet to ensure that their products are consistently high in quality, from batch to batch, for their intended use in order to always prevent harm from occurring to the end user

Biography :

Bernice Brempong holds a Bachelor degree in Pharmacy from University of Ghana, Legon. She has extensive experience in hospital practice, community practice and pharmaceutical production. She has worked in several pharmaceutical industries including Ernest Chemist in 2013 and Entrance Pharmaceuticals in 2016/2017 where she gathered practical experience and later assumed the Chief Executive Officer position in Makhealth Pharmaceuticals Limited. Makhealth Pharmaceuticals is currently putting up a WHO-GMP compliant facility in collaboration with international partners for the production of solid and liquid oral dosage forms and sterile products including dropper products, parenteral and vaccines. Makhealth intends to collaborate internationally in contract manufacturing and also to act as the state-of-the-art manufacturing industry in Sub-Saharan Africa.
Email:mbremps@gmail.com