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When is Excipient Reduced Testing Appropriate October 10-11, 2006 TOPIC E Closing Presentation

Learn about actions to assure excipient quality for global drug products and navigate non-harmonized tests in the compendia. Topics include stringent tests, vendor testing, critical attribute testing, and documentation justification. Also, explore regulatory approaches and effective use of PDG harmonization.

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When is Excipient Reduced Testing Appropriate October 10-11, 2006 TOPIC E Closing Presentation

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  1. When is Excipient Reduced Testing Appropriate October 10-11, 2006TOPIC EClosing Presentation Moderator: David ShortScribes: Kevin Moore; Justin Lane

  2. What kinds of actions should be performed to assure an excipient’s quality for global drug products when there are a number of non-harmonized tests in the global (USP, EP, JP) compendia? Topic #1

  3. Use the most stringent tests based on a “paper” review, and not evaluated in the laboratory. Rely on vendor testing Need to develop relationships and communication channels with vendors for certification/qualification programs. Should always test critical attributes. Need to include documentation for justification in case of inspection down the road. Looking at results from the survey, some significant number of firms are using a combined number of strategies. Comments to Topic #1

  4. One word in the CFR causes confusion the use of the term – “test” instead of “evaluate” The chemical industry is not going to do every test to demonstrate compliance if it is not necessary to perform such test to demonstrate control of their process. USP allows for alternate equivalent methodology as stated in the General Notices, but EP does not. Because of this, the EP test is chosen over the USP test. Meet the requirements for the COA by performing tests that they felt were of critical importance. Is there any guidance from FDA/ICH? Comments to #1 (cont)

  5. When can industry start implementing a new signed off harmonized general chapter? Once it is published in USP/NF? Wait until the delayed implementation date? When ICH Q4B has been completed? Topic #2

  6. FDA - Because of the potential for changes in implementation dates, retractions, and revisions, it maybe advisable to wait until implementation is required. Applicable to any chapter with delayed implementation. Clarification needed from FDA – expectations on industry with regards to the date of FDA enforcement to official date of USP implementation. Scenario A: Upon publication, 6 months exist before implementation – either version can be used within this time. Scenario B: Upon publication prior to implementation, FDA will not enforce new chapter. After implementation, a 6 month opportunity exists to implement the new requirement. Incorrect Comments to Topic #2

  7. What are the regulatory approaches when industry uses EP or JP test results to meet USP/NF requirements? Topic #3

  8. Depends on details for the regulatory filing. Mostly annual reportable. Question was asked if FDA want CBE-30’s on multiple drug applications as a result to a change in requirements as a result to harmonization. FDA reported that this depended on the criticality of the test parameter. For non-critical, an annual update was acceptable. Comments to Topic #3

  9. How should industry make effective use of PDG harmonization in light of the resulting changed excipient monographs. Industry will make use of the PDG excipient harmonized monographs where appropriate. Topic #4

  10. One word in the CFR causes confusion the use of the term – “test” instead of “evaluate” The chemical industry is not going to do every test to demonstrate compliance if it is not necessary to perform such test to demonstrate control of their process. Clarification is needed by FDA especially with regard to the PAT Environment. Justification to not test (eg. OVI) Closing Questions / Comments

  11. Applicable to any chapter with delayed implementation Scenario A: Upon publication, 6 months exist before implementation – either version can be used within this time. Scenario B: Upon publication prior to implementation, FDA will not enforce new chapter. After implementation, a 6 month opportunity exists to implement the new requirement. Incorrect - There is no grace period after the official date. You can use the method once it is published as official . Endorsement is needed by FDA. Closing Questions / Comments

  12. Changes to an application should be relevant to the information in the application. Most compendial changes for excipients would not require any notification to FDA (not even Annual Report). FDA should revise regulations and guidance. Closing Questions / Comments

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