The EU 2015/C 95/02 guidance for risk assessment of excipients require Drug Product Manufacturers or MAH holders to perform risk assessment and ensure excipients are suitable for use in pharmaceutical products. The risk assessment should be performed considering source risk of excipients (plant or animal origin, mineral origin, chemical synthesis etc) and function of the excipient in the drug product (binder, disintegrant, coating agent, colourant and so on). Functional risk should consider all the drug products in which excipient is used. Further appropriate GMP elements applicable for the excipient should be identified and a gap analysis should be performed. Based on gap analysis appropriate GMP elements should be identified.
While the Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use (EU 2015/C 95/02) provides a broad framework, it does not provide detailed instructions to perform this assessment.
Qvents post Excipient Risk Assessment: Approach, Templates provides comprehensive templates to perform and document excipient risk assessment. It also provides a tool to perform step by step assessment and generate Excipient Risk Assessment report and Control strategy (https://qvents.in/eugmp-excipient-risk-assessment-tool-template-source-functional-risk-control-strategy/)
The EU 2015/C 95/02 guidance for risk assessment of excipients require Drug Product Manufacturers or MAH holders to perform risk assessment and ensure excipients are suitable for use in pharmaceutical products. The risk assessment should be performed considering source risk of excipients (plant or animal origin, mineral origin, chemical synthesis etc) and function of the excipient in the drug product (binder, disintegrant, coating agent, colourant and so on). Functional risk should consider all the drug products in which excipient is used. Further appropriate GMP elements applicable for the excipient should be identified and a gap analysis should be performed. Based on gap analysis appropriate GMP elements should be identified.
While the Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use (EU 2015/C 95/02) provides a broad framework, it does not provide detailed instructions to perform this assessment.
Qvents post Excipient Risk Assessment: Approach, Templates provides comprehensive templates to perform and document excipient risk assessment. It also provides a tool to perform step by step assessment and generate Excipient Risk Assessment report and Control strategy (https://qvents.in/eugmp-excipient-risk-assessment-tool-template-source-functional-risk-control-strategy/)