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How characterization of excipient physical and chemical properties helps build quality into drug products

Topic B Closing Presentation Dr. Brian Carlin. How characterization of excipient physical and chemical properties helps build quality into drug products. Responsibility for testing Legal liability rests with user No regulatory restriction on whether user or supplier does the testing

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How characterization of excipient physical and chemical properties helps build quality into drug products

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  1. Topic B Closing Presentation Dr. Brian Carlin How characterization of excipient physical and chemical properties helps build quality into drug products

  2. Responsibility for testing Legal liability rests with user No regulatory restriction on whether user or supplier does the testing No requirement to duplicate other than ID What to test/why to test/how to test as a part of inclusion in QbD-based applications Highlights

  3. Additional cost should be borne by excipientuser; offset by increased efficiency (eg. Reduced rejection of drug product batches) Highlights

  4. 21st Century cGMP initiative is beneficial to all parties Reduced regulatory oversight Flexibility, continuous improvement Requires informed user-supplier collaboration Highlights

  5. Functionality transcends the excipient As applied to formulation and manufacturer process Not to be included in monograph Testing methodology should be in general chapter Customized between supplier and user Highlights

  6. Change notification All “significant” changes should be notified by excipient manufacturer and impact assessed and monitored by drug product manufacturer. Who defines significant? Supplier often unaware of application Highlights

  7. The onus of evaluating multiple source excipients lies with the user Assumption of new supplier as a minor change often not valid “non-critical” excipients can become critical if detrimental, eg. drug degradation Highlights

  8. IPEC/USP to challenge EP Functionality Related Characteristics (FRCs) whether non-mandatory or not More early interaction between center, field, and sponsor for QbD-based applications Actions

  9. Clarify who defines significant change Users to ensure oversight of purchasing decisions by R&D and other QA/technical groups Improve communication between purchasing and technical functions Improve communication between user and supplier Actions

  10. Change control should be part of the quality agreement between user and supplier Audits of suppliers should be a team effort which, in addition to GMP compliance, includes technical functions. Actions

  11. Develop education programs focusing on formulation science/QbD collaboratively between academia and industry Actions

  12. Need to define Significant Change in Quality agreements. Closing Questions / Comments

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