Improving the Quality of Generic Drugs

This white paper reviews the present state, current challenges, and recommended best practices for improving the quality of prescription pharmaceuticals, with an emphasis on generic pharmaceuticals. This white paper covers the following topics:

• Quality Management Systems
• Quality Control
• Public health impact
• Regulatory guidelines
• Auditing/Inspections

This white paper addresses key policy issues, best practices, and key challenges around the pharmaceutical value chain that has an impact on quality of pharmaceuticals available to patients. This white paper also discusses the key stakeholders involved in the quality of medicines (i.e. regulatory bodies, policymakers, and drug manufacturers) and recommendations for future actions.