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Presentation Outline. History and OverviewQ4B ProcessCurrent Activities for the Q4B Expert Working Group (EWG)Implementation Considerations. The harmonization of particular compendial test sections has been considered as basic by the ICH Steering Committee to achieving full utility of the ICH Q6A rule. Industry requests that ICH SC make an EWG to address administrative acknowledgment (3 areas) of mischief
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ICH Q4B Regulatory Acceptance of Analytical Procedures as well as Acceptance Criteria (RAAPAC) Overview and Update Robert H. Ruler, Sr. Office of Pharmaceutical Science, CDER, FDA Advisory Committee for Pharmaceutical Science (ACPS) October 5, 2006

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Presentation Outline History and Overview Q4B Process Current Activities for the Q4B Expert Working Group (EWG) Implementation Considerations

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Background The harmonization of particular compendial test sections has been considered as basic by the ICH Steering Committee to accomplishing full utility of the ICH Q6A rule. Industry requests that ICH SC make an EWG to address administrative acknowledgment (3 locales) of fit pharmacopeial techniques from EP/JP/USP (PDG) – July 2003 ICH SC builds up Q4 EWG with an extension to address 11 General Test Chapters talked about amid improvement of ICH Q6A Guideline - November 2003 SC endorses Q4B Work Plan – April 2004

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Background (Continued) SC favors advancement of an ICH Guideline – June 2004 Q4B EWG starts assessing PDG orchestrated content – November 2004 Step 2 ICH Q4B Guideline affirmed by SC – June 2006 first Annex (Residue on Ignition/Sulphated Ash) endorsed June 2006 FDA Draft Guidances imprinted in FR August 2006 (60-day remark period)

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Q6A-related General Chapters Dissolution   Disintegration  *Uniformity of Content *Uniformity of Mass Extractable Volume  Particulate Matter  Sterility  Microbiological Quality  Bacterial Endotoxins  ROI/Sulphated Ash Color and Clarity (per ICH SC, work will simply be on "Colour")  ______ * Harmonized to Uniformity of Dosage Units

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What is PDG? Pharmacopeial Discussion Group (PDG) involved delegates of the United States Pharmacopeia (USP), Japanese Pharmacopeia (JP), and the European Pharmacopeia (Ph.Eur. on the other hand EP) Multi-step procedure to orchestrate chose general test techniques and monographs May bring about some remaining or nearby contrasts that may posture issues for controllers – Q4B/PDG cooperation to determine issues

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PDG Process Results in Harmonized Text Individual Pharmacopeial Approval & Official Printing Process JP Version ________ ____ ____________ ___ ____ _____ ___ _________ ____________ _________ ___ ____________ USP Version ____ ___ _____ ____________ ___ ____ _____ ____________ EP Version ____________ ___ _________ ___ ____ _____ ____ ___ ____________ ________________________ Do contrasts affect on the capacity to accomplish same result with same acknowledge/dismiss ability?

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Q4B Process Steps FOR EACH TOPIC: PDG gives to Q4B Expert Working Group: PDG-orchestrated content JP/EP/USP draft form of how blended content will be actualized in their compendia Briefing note to depict any nearby contrasts or potential issues Printing course of events to move every pharmacopeia to authority status Q4B part parties take the records back to their constituents for autonomous assessment

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Q4B Process (proceeded) Q4B EWG audits the assessments Issues examined inside Q4B EWG for conceivable determination Evaluation results and conceivable determination instruments passed on back to as well as talked about with PDG Once issues are settled, Q4B EWG prescribes endorsement (ICH Step 2) to the ICH SC – begin of Annex process

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PDG Document Submission Step 1: Q4B EWG appraisal and add advancement Step 2: ICH Sign off on draft Q4B add Regional pharmacopoeial usage Step 3: Regulatory Consultation on add Step 4: Annex received by ICH Steering Committee Step 5: Regional administrative execution Inter-local Acceptance Topic Specific Annex Process PDG Process ICH Process

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What Q4B Activity Is Effective approach to raise and resolve issues that may affect both industry and controllers. For FDA, compatibility implies the conceivable utilization of the fit techniques for JP and EP, where esteemed fitting and in view of our logical survey, to be considered as identical to the USP strategy. An investment funds in time and exertion: More so to industry to all inclusive bring together testing techniques [for applications and other administrative (consistence) needs] – one test as opposed to three To conceivably diminish or dispose of the need to experience a defense system with regards to the utilization of other compendial strategies (done one an opportunity to wipe out dreary avocations)

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What Q4B Activity Is (proceeded with) Given the bound together approach and quality of working specifically with the three administrative areas, it is a viable approach to accomplice in the pharmacopeial procedure to impact change, where single, autonomous endeavors won\'t not be as fruitful. Keeps up FDA\'s survey power if there should be an occurrence of any question, the nearby territorial strategy wins. Builds up a procedure for multi-focus contribution to logical audit for deciding the compatibility.

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What Q4B Activity Is Not It won\'t be a system to supplant FDA\'s CMC audit procedures and order. It will be up to the CMC commentator and the support to build up what are the best strategies and acknowledgment criteria to guarantee a sheltered and solid item It won\'t rethink the compendial update cycle that brought about the PDG blended content - Industry and controllers have their contribution amid the individual amendment forms It won\'t set up acknowledgment criteria outside of typical procedures

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Q4B Activity for Chicago Meeting Work keeping on moving Q4B Guideline and 1 st Annex to ICH Step 4/5 Finalize 2 nd Annex for "Extractable Volume" to ICH Step 2 and move to administrative expert (ICH Step 3) Work proceeding on assessment of other PDG fit content entries: Sterility Test Particulate Matter Dissolution Other general test sections to come

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Implementation Considerations Each finished subject moved to FDA Guidance for Industry Transparency for industry and controllers FDA partner Work Group framed for mindfulness and preparing in respect to the Q4B procedure. Representation from: CDER ( ONDQA, OGD, OBP, OTR, Office of Compliance ) CBER CVM ORA

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Acknowledgments My gratitude to: Cindy Buhse Jon Clark

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