Transcript Slide 1
How characterization of excipient physical and chemical properties helps build quality into drug products Topic B Closing Presentation Dr. Brian Carlin Highlights 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 Additional cost should be borne by excipient user; offset by increased efficiency (eg. Reduced rejection of drug product batches) Highlights 21st Century cGMP initiative is beneficial to all parties • Reduced regulatory oversight • Flexibility, continuous improvement • Requires informed user-supplier collaboration Highlights 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 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 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 Actions IPEC/USP to challenge EP Functionality Related Characteristics (FRCs) whether non-mandatory or not More early interaction between center, field, and sponsor for QbDbased applications Actions 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 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 Develop education programs focusing on formulation science/QbD collaboratively between academia and industry Closing Questions / Comments Need to define Significant Change in Quality agreements.