Pharmaceutical Regulatory Affairs and IPR

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  arketing 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.