5/13/08. Quality by Design. Gail Burnett, Ph.D. 2005, Genentech

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1 Quality by Design Gail Burnett, Ph.D.

2 Agenda Quality by Design Slide 2 Background on ICH Q8, Q9, and Q10 Quality by Design (QbD) Definitions QbD Framework The What, Why, and How of QbD

3 The New Paradigm of ICH Q8, Q9, Q10 Slide 3 The new Paradigm Q8 Q10 Q9

4 The Role of Process Understanding Slide 4 A Process is well understood when all critical sources of variability are identified and explained; variability is managed by the process; and, product quality attributes can be accurately and reliably predicted over the design space

5 ICH Q8 Summary Slide 5 ICH Q8 Basic Guideline Defines what is the minimum (Base Line) The role of Process Understanding Defines what is a Design Space Defines Regulatory Flexibility ICH Q8(R1) Defines what is Quality by Design The role of a Systematic Approach Defines Critical Quality Attribute Examples of Design Space Defines Control Strategy

6 ICH Q8(R) : Quality by Design Slide 6 Important Elements: Systematic approach Predefined objectives (Target Product Profile) Product and process understanding based on sound science Quality risk management

7 Q8 General Concepts: What we get in return Slide 7 This scientific understanding facilitates establishment of an expanded design space. In these situations, opportunities exist to develop more flexible regulatory approaches, for example, to facilitate: risk-based regulatory decisions (reviews and inspections); manufacturing process improvements, within the approved design space described in the dossier, without further regulatory review; reduction of post-approval submissions; real-time quality control, leading to a reduction of end-product release testing.

8 ICH Q9: Quality Risk Management Slide 8 Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation Team approach R i s k C o m m u n i c a t i o n Risk Control Risk Reduction Risk Acceptance Output / Result of the Quality Risk Management Process unacceptable R i s k M a n a g e m e n t t o o l s Risk Review Review Events

9 ICH Q10 Pharmaceutical Quality Systems Slide 9 Key aspects of the Pharmaceutical Quality System Management Responsibility Product Realization Continual Improvement Product and Processes Quality System

10 QbD Definitions Slide 10

11 QbD Definitions Slide 11 Design Space: Critical Quality Attribute (CQA):

12 Quality by Design Framework Slide Create the Knowledge Space 2. Create the Design Space 3. Link to Quality Systems

13 QbD Framework Slide Create the Knowledge Space Identify the Critical Quality Attributes (CQAs) Apply QbD by Unit Operation, working backwards from Drug Product Do a Risk Assessment on each Unit Operation Conduct Designed Experiments

14 QbD Framework Slide 14

15 CQA Assessment Slide 15 Use CQA assessment to guide development plan Declare non-critical those attributes that are demonstrated through product specific or platform knowledge to not impact safety, efficacy, or potency across a broad range Focus product characterization and process development activities on attributes that have potential of impact (presumptive or potential CQAs = pcqas) Discussion point: Is criticality of an attribute related to control? A product profile (e.g. chromatogram) can be a quality attribute. Should product attributes and process impurities be handled the same?

16 QbD Framework Slide 16

17 QbD Framework Slide 17

18 QbD Framework Slide 18

19 QbD Framework Slide

20 QbD Framework Slide 20

21 QbD Framework Slide Create the Design Space Identify the Critical Steps Identify Critical Process Parameters Identify Critical Input Variables

22 QbD Framework Slide 22 Acceptable Range Acceptable Range

23 QbD Framework Slide 23 Acceptable Range Acceptable Range

24 QbD Framework Slide 24 Acceptable Range Acceptable Range

25 QbD Framework Slide Link to Quality Systems (Q10) Documentation of Quality Attributes Approve Specifications Documentation of Manufacturing Process (Parameters and Input Variables) Validation Change Control Deviations, Discrepancies, and Investigations

26 Specifications for Quality Attributes Slide 26 Should all CQAs have specifications? Must all Specifications be demonstrated for each batch on a CoA? Should some CQAs just be used for comparability? If process is demonstrated (validated) to achieve the desired level or range of a quality attribute, is a specification needed? What about removal of process impurities? What about viral clearance? Should specifications allow the full acceptable ranges of critical quality attributes? Attributes that we test for process consistency (not CQAs) should have or action / alert limits

27 QbD Framework Slide 27 Link to Quality Systems Manufacturing Documentation to reflect critical parameters and input variables Validation should focus on CPPs Change Control allows change within design space Deviations, Discrepancies, and Investigations may be reduced by better process knowledge QbD leads to identification of critical quality attributes, process steps, and process parameters, which provides focus to specifications, validation protocol, batch record and controls

28 Quality by Design Submissions Slide 28 CQAs must be defined before BLA/NDA filing and should include those attributes that have been demonstrated to impact safety, efficacy, or potency of the drug or have high potential to do so (but still unknown) and are not easily controlled. QbD may be applied to entire process or to selected unit operations How should we describe Quality Attributes and Design Space in Regulatory Filings? Better understanding of process and product can lead to better science and risk-based regulation of individual products Continue to work with Regulatory Agencies and Industry groups to advance QbD.

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