The purpose of quality assurance in public drug supply systems is to ensure that drugs that reach patients are safe, effective, and of standard quality. A comprehensive quality assurance program includes both technical and managerial activities, covering the entire supply process from drug selection to patient use. There are a variety of factors that affect drug quality, including but not limited to manufacturing processes, packaging, transportation, storage conditions.
Technical activities in a typical quality assurance program include pharmaceutical product documentation, performing and reviewing quality control laboratory tests and monitoring product stability over time. Managerial activities include selecting suppliers, preparing effective contract terms, monitoring supplier performance and enforcing drug inspection procedures throughout the distribution network.
Empower’s expertise lies in quality assurance in the entire drug supply chain; we assess product quality based on this continuum. Products registered in ICH countries, EFTA, or that are prequalified by WHO, are termed as “Quality Assured products”. On the other hand, products registered in PIC/s countries, approved by International Procurement Agents (e.g. IDA, IMRES, MEG) and approved by Global Health Organizations (e.g. PSI, MSI etc.), are termed as Quality Verified products. We have worked with various organizations like UN agencies (UNDP, UNFPA etc.), Ministries of Health (Zimbabwe, Zambia, Nigeria, Sudan, South Sudan, and Ethiopia etc.), Donor agencies (DfID) and others.
See below for Quality Assurance requirements in Procurement and Supply Chain
For more details, please see our projects in Quality Assurance.