Update on Lessons Learned from the EMA-FDA QbD Pilot

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1 Update on Lessons Learned from the EMA-FDA QbD Pilot IFPAC 2014 Annual Meeting 22 January 2014 Sharmista Chatterjee, Ph.D. CMC Lead for QbD, ONDQA/OPS/CDER/FDA

2 Background One of the projected outcomes of the pilot: Joint presentations of key findings will be presented publically through conferences and/or publications, as appropriate Findings have been jointly presented via: Multiple international conferences Two Q&A documents

3 Q&A Documents Jointly published by both EMA and FDA Based on learning's from the first parallel assessment application Includes comments from PMDA Objective: To serve as a reviewer guide Communication to industry/academia Method of publishing: FDA : Web updates EMA : Press release Publication timelines: Q&A Set (1) published on Aug 20, 2013 Q&A Set (2) published on Nov 1, 2013

4 3 Q&A (1) : QTTPs and CQAs

5 4 Q&A (1) - Criticality

6 Q&A (1) - Level of Detail in Manufacturing Process Description The manufacturing process description should be adequately detailed and include all relevant parameters (both critical and non critical) with their target values or ranges. Describe steps in a sequential manner including batch size(s) and equipment type Difference: FDA can accept Master Production Record (MBR). for drug product manufacturing (Required for generic and (b)(2) products.) 5

7 6 Q&A (1) - ATP, MODR

8 Q&A (2) : Design space Verification -1 Why would a design space be verified during the product lifecycle? - Demonstrates that good quality product is obtained throughout the design space -Typically limited design space verification at the time of submission - Verification typically occurs at or near target operating ranges - Potentially high risks areas might not have been verified - Movements to commercially unverified areas can pose risks to quality due to potential scale up effects or model assumptions - If a design space is demonstrated as scale independent, then additional mitigation steps may not be necessary

9 Q&A (2) : Design space Verification - 2 How can a design space be verified at commercial scale? - Not necessary to: - Repeat at commercial scale all the experiments that were conducted at pilot scale to define the design space -To verify entire commercial scale design space at the time of submission -To identify the edge of failure - Verification approach guided by risk assessment - Management of risk can include additional monitoring that is not included in the routine control system - Plans for design space verification included in design space verification protocol

10 Q&A (2): Regional Expectations Both agencies expect the following to be included in the site s quality system Detailed approach for design space verification Documentation of any verification data Differences in expectation FDA: Recommended to include in the submission a high level overview of the plan for design space verification EMA: Protocol for design space verification be submitted in section 3.2.R of the application; protocol is assessed at the time of review

11 Areas of Future Q&A (1) Level of detail in application/dossier Level of detail regarding: Risk assessment, Design of Experiment (DOE), Justifying a design space Commensurate with significance to product design and the commercial manufacturing process and its control strategy Continuous Manufacturing Possible topics: control strategy consideration, approach for process validation

12 Areas of Future Q&A (2) Implementation of NIR (Near Infrared) Areas for harmonization include: Distribution of samples in calibration and validation set For example, if NIR is used for CU, what range should be covered? External validation: is commercial scale data needed? Sample distribution within a design space Parallel testing vs. external validation How much data to demonstrate that the NIR model can handle normal variability seen at commercial scale?

13 Publish draft Q&A Next Steps Continue to communicate agencies harmonized view points via additional Q&A, journal communications, white papers

14 Conclusions ARE WE THERE YET? 2 Q&A Doc FDA-EMA Pilot ICH IWG PtC ICH IWG Q&A ICH Q8-11

15 Acknowledgements: US FDA: C. Moore, D. Henry, B. Kurtyka, J. Martin ONDQA reviewers EU PAT Team: J-L Robert, K.Pugh, L.Ertle, L. Martinez Peyrat, A. Aggarwal EMA: A-M Van Nederkassel, C. Garcia Burgos, H. Dolores 14

16 To discuss your QbD submission in EU: Contact the PAT Team Seek formal scientific advice To discuss your new drug QbD submission in US: Contact the Clinical Division and/or CMC Project Manager to request a meeting Address general questions to: newdrugcmc@fda.hhs.gov 15

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