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Presented By
Bindiya Patel
M.PHARM
(PHARMACEUTICS)
Aim
Objective
Introduction
System Before Q8
QbD
ICH Q8 Material Attributes
ICH Q8 Formulation
Contents For 3.2.P.2
Formula...
 To review and study ICH guidelines Q8
 To understand the concept of ICH guidelines Q8
 To know the importance and stud...
High level purpose of Q8 is –
1. To provide [harmonised] guidance on the contents of
section 3.2.P.2 (pharmaceutical devel...
Describes good practices for pharmaceutical
product development
„Introduces concepts of
1. „Design space „
2. Flexible reg...
1. Product quality and performance achieved and assured by
design of effective and efficient manufacturing
processes.
2. P...
 Create a basis of flexible regulatory approaches by
reducing uncertainty.
1. Facilitate risk based regulatory decisions....
A systematic approach to development that begins
with predefined objectives and emphasizes product
and process understandi...
9
Variable X
Variable Y
Traditional process – limited knowledge – 3 batches, any
change needs new data and new approval
Ne...
Higher level of assurance of product quality
„Cost saving and efficiency for industry
1. Increase efficiency of manufactur...
Drug substance
–physicochemical and biological properties in relation to
product performance and manufacturability
Excipie...
Summary describing
1. Pharmaceutical development from initial concept to
final design.
2. Identification of attributes and...
Part 1
Core document
Baseline expectations
Optional information
Regulatory Flexibility
13
Revision
Annexes relating to
spe...
14
Product
development
Technology
transfer
Commercial
manufacture
Demonstration of
greater under-
standing of
pharmaceutic...
 3.2.P.2.1 Components of drug product (drug
substance/ excipients)
 3.2.P.2.2 Formulation Dev.
 3.2.P.2.3 Manufacturing...
Activities ICH Q8(R2) – Pharmaceutical
Development
Related Activities
Process Screening • Exploration of unit operations
•...
Activity ICH Q8(R2) – Pharmaceutical
Development
Related Activities
Technology Transfer • Gain product and process knowled...
Define Target Product Profile
Identify ‘CQAs’ – Critical Quality Attributes of Product
Determine QAs of inputs – materials...
REGULATORS INDUSTRY
1. Promote open communication
2. Reviewers who are
accessible, engaged, and
expert
3. Change the conte...
ExistingExisting GMPGMP’’ss
Quality by Design
(Pharmaceutical
Development)
Quality Risk
Management
The Regulatory
Quality ...
Agencies and Industry are moving from ‘blind’ compliance to
‘science and risk-based’ compliance Industry wants this to be
...
22
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ICH Guideline Q8 Pharmaceutical Development

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ICH Guideline Q8 Pharmaceutical Development

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ICH Guideline Q8 Pharmaceutical Development

  1. 1. Presented By Bindiya Patel M.PHARM (PHARMACEUTICS)
  2. 2. Aim Objective Introduction System Before Q8 QbD ICH Q8 Material Attributes ICH Q8 Formulation Contents For 3.2.P.2 Formulation Development Activities Commercial Manufacturing Activities Q8 Annexure Future State Vision Conclusion 2
  3. 3.  To review and study ICH guidelines Q8  To understand the concept of ICH guidelines Q8  To know the importance and study the benefits of ICH guidelines Q8 3
  4. 4. High level purpose of Q8 is – 1. To provide [harmonised] guidance on the contents of section 3.2.P.2 (pharmaceutical development) for new drug products. 2. An opportunity to present the knowledge gained through the application of scientific approaches to product and process development (= scientific understanding) . 3. Consult with the appropriate regulatory authorities. 4. Adoption of Q8 philosophies can create a new paradigm and set of opportunities for Industry and Regulators. 4
  5. 5. Describes good practices for pharmaceutical product development „Introduces concepts of 1. „Design space „ 2. Flexible regulatory approaches „ 3. Quality Risk Management (Q9) „ Does not discuss QbD 5
  6. 6. 1. Product quality and performance achieved and assured by design of effective and efficient manufacturing processes. 2. Product specifications based on mechanistic understanding of how formulation and process factors impact product performance. 3. An ability to effect Continuous Improvement and Continuous "real time" assurance of quality. 6
  7. 7.  Create a basis of flexible regulatory approaches by reducing uncertainty. 1. Facilitate risk based regulatory decisions. 2. Continuous improvements without the need for regulatory review. 3. ”Real time” quality assurance. 7
  8. 8. A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Design Space : the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. 8
  9. 9. 9 Variable X Variable Y Traditional process – limited knowledge – 3 batches, any change needs new data and new approval New paradigm: influence of factors explored creating knowledge. Risk analysis of impact of change is possible. Approval to move within defined area post- approval could give flexibility for continuous improvement without need for further approval
  10. 10. Higher level of assurance of product quality „Cost saving and efficiency for industry 1. Increase efficiency of manufacturing process „2. Minimize/eliminate potential compliance actions 3. „Provide opportunities for continual improvement 4. Facilitate innovation „ More efficient regulatory oversight 1. „Enhance opportunities for first cycle approval. „2. Streamline post approval manufacturing changes and regulatory processes. 10
  11. 11. Drug substance –physicochemical and biological properties in relation to product performance and manufacturability Excipients - concentration, characteristics and functionality in relation to product performance and manufacturability - functionality during shelf-life 11
  12. 12. Summary describing 1. Pharmaceutical development from initial concept to final design. 2. Identification of attributes and interacting variables critical for product quality i.E. Drug substance, excipients (ranges), container closure system, dosing device (if relevant), manufacturing process. 3. Formulations from pivotal clinical safety/efficacy studies. 12
  13. 13. Part 1 Core document Baseline expectations Optional information Regulatory Flexibility 13 Revision Annexes relating to specific dosage forms (as Q6a) References to use of risk management Focus on guiding towards Desired State Step 4: Nov 2005 Drafting underway
  14. 14. 14 Product development Technology transfer Commercial manufacture Demonstration of greater under- standing of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. Design quality product & process to consistently deliver intended performance. Manufacturing process improvements, within the approved design space, without further regulatory review.
  15. 15.  3.2.P.2.1 Components of drug product (drug substance/ excipients)  3.2.P.2.2 Formulation Dev.  3.2.P.2.3 Manufacturing Process Development  3.2.P.2.4 Container Closure System  3.2.P.2.5 Microbiological Attributes  3.2.P.2.6 Compatibility 15
  16. 16. Activities ICH Q8(R2) – Pharmaceutical Development Related Activities Process Screening • Exploration of unit operations • Characterization of process intermediates Process Development and Optimization (Lab Scale) • DOEs for process parameters and interactions with material attributes • Development of Design Space • understanding of critical process operations Process Development and Optimization (Pilot Scale) • DOEs for process parameters and interactions with material attributes • Development of Design Space • understanding of critical process 16
  17. 17. Activity ICH Q8(R2) – Pharmaceutical Development Related Activities Technology Transfer • Gain product and process knowledge • Knowledge supports transfer between development and manufacturing to achieve product realization Commercial Scale Manufacturing for Drug Product • Definition of commercial process design • Commercial scale runs to verify process design, with additional sampling to verify understanding • Implementation of on-line measurement technologies Continual Process Verification and Continual Improvement • On-going analysis and trending of process data, (multivariate SPC, etc.) • Evaluation of process changes and 17
  18. 18. Define Target Product Profile Identify ‘CQAs’ – Critical Quality Attributes of Product Determine QAs of inputs – materials/parameters etc. Select appropriate process Determine functional relationships between material attributes & process parameters to Product CQAs Identify a control strategy Propose a “design space” Define and describe design space in regulatory submission 18
  19. 19. REGULATORS INDUSTRY 1. Promote open communication 2. Reviewers who are accessible, engaged, and expert 3. Change the content of applications Encourage knowledge sharing Eliminate non-value added information 4. More science & risk-based evaluation of applications 5. Reduce post-approval change regulatory hurdles 1. Be open and transparent in sharing knowledge: success and failure. 2. Scientists can understand the needs of the Regulators. 3. Change the content of applications. -Share the knowledge. -Focus on manufacturing sciences. 1. Move to science-based, risk mitigated applications 2. Provide insight into manufacturing sciences so as to reduce need for post-approval change 19
  20. 20. ExistingExisting GMPGMP’’ss Quality by Design (Pharmaceutical Development) Quality Risk Management The Regulatory Quality System Our vision: The future Pharmaceutical Quality System Quality Systems Quality Systems (Q10) For companies with : 1. Good design and control strategies 2. Good Risk Management strategies 3. Good Quality Systems Quality Risk Management (Q9) Quality by Design (Q8) Reduced regulatory burden: • Reduction of submissions on changes/variations • Inspection of quality systems 20
  21. 21. Agencies and Industry are moving from ‘blind’ compliance to ‘science and risk-based’ compliance Industry wants this to be global. This evolution is based on process understanding and continuous improvement throughout the product life cycle Traditional process validation being replaced by a much better alternative. - Building in quality. - Continuous quality verification and improvement. Moving from ‘Quality by Testing’ to ‘Quality by Design’ should, in principle, allow significant regulatory flexibility helps both regulators and industry focus on higher risk or added value activities. 21
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