ICH Q8, 9 & 10 and the Impact on the QP

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1 1 ICH Q8, 9 & 10 and the Impact on the QP Peter H. Gough David Begg Associates

2 2 A New Approach to Regulation Approach to the regulation of pharmaceuticals is undergoing a paradigm shift Led by the American Food and Drug Administration (FDA) Started with Process Analytical Technology (PAT) and 21st Century GMP initiatives. These changes will directly impact on many aspects of quality management and the QP.

3 FDA s Concerns Current State of Pharmaceutical Manufacturing: Many product formulations and processes derived empirically Too little knowledge on fundamental mechanisms impacting product quality Very low efficiency and high cost Industry hesitant or afraid to use new technologies

4 FDA s Concerns FDA s CONCLUSION: Current approach likely to be inadequate to meet future needs FDA unable to deliver on their statutory inspection obligations Need to encourage greater emphasis on science and risk-based approaches

5 5 FDA Initiatives since 2001 PAT cgmp ICH GMP activities Critical Path Desired State

6 6 Process Analytical Technology (PAT) Not just testing but a philosophy of Control in-process rather than endproduct testing Minimises risks of poor quality

7 7 PAT Approach Quality by Design Identify the parameters that are critical to product quality Statistically designed experiments Measure these parameters Control these parameters Feed back Feed forward

8 8 Paradigm Shift Current paradigm: Starting Materials Processing parameters Product Variable Fixed Variable

9 9 Paradigm Shift PAT paradigm: Starting Materials Processing parameters Product Variable Variable Fixed

10 10 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals (ICH) for Human Use

11 11 ICH Participants Expert Working Groups (EWGs) Q uality S afety E fficacy M ultidisciplinary

12 12 ICH GMP Guidance EU, Japan and observers joined USA to define a new paradigm at an ICH GMP Workshop in Brussels, July 2003 Three guidance documents: Q8, on Pharmaceutical Development Q9, on Quality Risk Management Q10, on Pharmaceutical Quality Systems

13 13 Flexible Regulatory Approach Regulators evaluate risk, based on: Product and process design (Q8) Measures to evaluate and manage risks (Q9) Quality system implementation (Q10) Regulators determine risk and modify level of oversight accordingly for: Submissions Post-approval change review GMP inspections Result: Removal of barriers to continuous improvement Efficient use of resources by industry and regulators

14 14 ICH Quality GMP Related Activities - Current Status Q8 Pharmaceutical Development Approved by ICH in November 2005 Implemented in EU, Japan and USA during 2006 Q8(R1) at Step 3 of ICH process Q9 Quality Risk Management Approved by ICH in November 2005 Implemented in Japan & USA during 2006 but not yet in EU Q10 Pharmaceutical Quality Systems Draft formally issued for comment Expect final ICH approval in Spring of 2008

15 15 ICH Q8 Pharmaceutical Development

16 16 Q8 seeks to Deliver Product quality and performance achieved and assured by design of effective manufacturing processes Product specifications based on mechanistic understanding of how formulation and process factors impact product performance An ability to affect continuous improvement and continuous "real time" assurance of quality

17 17 Q8 Key Concepts Q8 is the way that PAT concepts can be integrated with the Regulatory process Information from pharmaceutical development studies is a basis for risk management (using Q9) Identify critical parameters, which carry the risk This assessment helps define the design space

18 18 Design Space Design space is the multidimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality.

19 19 Design Space Knowledge Space Design Space Batch process settings The batch process settings are NOT registered and, hence, moving them within the Design Space is NOT a change

20 20 Design Space Design space is the multidimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality.

21 21 n-dimensional Design Space Peat Describing Flavour Coffee (Flavour Space) Sweet Toast Batch process settings Interaction 2 Design Space n-d (Bulk Blend) % Moisture Particle Size Tobacco Chocolate Interaction 1 Surface Area Cinnamon % lubricant

22 22 ICH Q8 (R1) Received Step 2 approval 1 Nov Hoped to reach Step 4 in June 2008 ICH Q8 (R1) provides an annex to Q8 guideline. This annex elaborates the elements of pharmaceutical development as: Target Product Profile Critical Quality Attributes (CQA) Linking material attributes and process parameters to CQAs by risk assessment Design Space Control Strategy Product lifecycle management and continual improvement

23 23 ICH Q8 (R1) Design Space Concept of Design Space is elaborated upon with guidance on: Selection of variables Defining and describing a design space in a submission Unit operation design space(s) Relationship of Design Space to scale and equipment Design Space versus proven acceptable ranges Design Space and edge of failure

24 24 ICH Q8 (R1) Appendix 1 - Overall Development Minimal Approach Mainly empirical Developmental research often conducted one variable at a time QbD Approach Systematic, relating mechanistic understanding of input material attributes and process parameters to drug product CQAs Multivariate experiments to understand product and process Establishment of design space PAT tools utilised

25 25 ICH Q9 Quality Risk Management

26 26 ICH Q9 - Principles of Quality Risk Management Two primary principles: 1. The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient. 2. The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.

27 27 ICH Q9 Quality Risk Management Process

28 28 Risk Management Methodology Failure Mode Effects Analysis (FMEA) Failure Mode Effects & Criticality Analysis (FMCEA) Fault Tree Analysis (FTA) Hazard Analysis of Critical Control Points (HACCP) Hazard Operability Analysis (HAZOP) Risk Ranking and Filtering Preliminary Hazard Analysis (PHA) Supporting statistical tools Annex I: Short description Potential areas of use

29 29 Q9 - Implementation in EU Q9 was fully implemented in USA and Japan in 2006 NOT yet implemented in EU EMEA Q9 Implementation Group consisting of inspectors and regulatory assessors EU adoption expected to be as follows: Added as Annex 20 of GMP Guide Changes to Introduction and Chapter 1 of EU GMP Guide Revisions to some CHMP NfGs

30 30 ICH Q10 Pharmaceutical Quality Systems

31 31 ICH Q10 Objective The objective is to describe a model for an effective quality management system for the pharma. industry, referred to as the pharmaceutical quality system, that: Ensures the realisation of a quality drug product Establishes and maintains a state of control Facilitates continual improvement over the product lifecycle

32 32 Q10 Introduction Q10 will: Augment existing GMPs Provide a bridge between different regional regulations Complement and facilitate implementation of Q8 Pharmaceutical Development and Q9 Quality Risk Management

33 33 Q10 Introduction Implementation of Q10 should facilitate: Innovation and continual improvement throughout the product lifecycle and Strengthen the link between pharmaceutical development and manufacturing organizations.

34 34 Q10 - Enablers The enablers provide the means for science- and risk-based decisions related to product quality Knowledge Management Manage knowledge from development through commercialisation to discontinuation Quality Risk Management (Q9) Proactive approach to managing risks to quality

35 35 The Desired State Product quality and performance achieved by design Specifications based on mechanistic understanding of how formulation and process factors impact product performance Continuous real time assurance of quality

36 36 Impact on the QP Data interpretation Many recent changes place significant focus on data evaluation : ICH Q8 ICH Q9 Product Quality Reviews On-going stability QPs must be have good understanding of statistical techniques for data interpretation

37 37 Data, Information, Knowledge & QP Decisions QP Decisions: Based on knowledge Knowledge: Derived from combining information sources Information: Data: Derived from data using statistical analysis Derived from relevant samples using validated methods QP Decision Knowledge Information Data

38 38 Impact on the QP Batch certification A QP s primary legal duty is to certify that product has been made in accordance with the Marketing Authorisation (MA) Current MAs have of a defined method of manufacture i.e. a fixed process Future MAs will define a Design Space

39 39 Impact on the QP Q8 & Design Space The Design Space may well be a mathematical algorithm that defines an n- dimensional space Real-time release Changes within the Design Space will not require regulatory submissions Who will Authorities hold accountable for ensuring that there is a system for managing changes within the Design Space? The Qualified Person!

40 40 Impact on the QP Quality Risk Management (Q9) A good understanding of Quality Risk Management (QRM) is going to be crucial Who will Authorities hold accountable for the QRM process and the final Risk Acceptance decision? The Qualified Person!

41 41 Impact on the QP Quality Systems (Q10) Senior management are ultimately responsible for the Quality System Who will they delegate the task of developing and implementing the PQS to? The Qualified Person?

42 42 Impact on the QP Quality Systems (Q10) The QP should NOT have to be the architect of the PQS The QP should be the auditor of the PQS The QP must monitor and be able to influence the content and implementation of the PQS

43 43 Impact on the QP Summary The new paradigm for pharmaceutical regulation is still developing QPs must keep up with the evolving expectations ICH Q8, 9 & 10 may be largely written but it is the interpretation over coming years that is going to be crucial for QPs QPs have the opportunity to influence the development of this new approach The QP is going to be key to implementing the new paradigm

44 44 Impact on the QP Summary The future for the QP is going to be much more interesting and stimulating than just reviewing batch records!

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