Pharmaceutical Quality Systems Support

Adherence to regulations within the drug manufacturing industry is critical to ensure patient safety and pharmaceutical business success. This requires the maintenance of consistent quality manufacturing supported by an active management community, comprehensive quality management systems that are continuously updated, and adherence to Good Manufacturing Principles. The Pharma Quality Systems Support Portal serves to provide resources and educational support to assist stakeholders within the pharmaceutical industry and government regulatory bodies.

Focus Areas

This website intends to support FDA and other national and international pharmaceutical regulatory authorities to ensure the quality of pharmaceutical and food products, protect consumers health and safety and build capacity of pharmaceutical and food industry workforce.

Find out more

Pharmaceutical production in developing countries has long been seen as a potential way to increase access to medicines and improve public health. There have been significant advancements in science and engineering to support the pharmaceutical manufacturing. However, there are several challenges in pharmaceuticle production and quality assurance in developing countries. The objective is to contribute improving the operational environment and technical capacities of pharmaceuticle manufacturers.

Find out more

Postmarketing surveillance is an essential part of distribution and supply of pharmaceuticle products to prevent the supply of Substandard and Falsified (SF) Medical Products and to conduct Pharmacovigilance. As all possible side effects of a drug can’t be anticipated based on preapproval studies involving only several hundred to several thousand patients; therefore, U.S. Food & Drug Administration (FDA) maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process. This website intends to assit FDA in postmarketing surveillance by engaging local and international networks.

Find out more

Latest news

Join us

Subscribe to our Newsletter