There are a large number of economic and quality-related reasons for a pharmaceutical company (proprietary or CMO) to adapt Quality by Design (QbD) for their products. The course will cover the economics of PAT (Process Analysis Technology) and QbD, Agency (FDA, EMA) Guidances and regulations (CFR), and ICH Guidances that both allow and encourage companies to engage in QbD. This curriculum will apply to both new and legacy products. The formation of a working committee to direct and oversee the QbD project will be discussed in detail… this could be the step most needed for a successful QbD program.
The manner in which a product is chosen, using quality and financial parameters, will be discussed in detail with examples, given (attendees are encouraged to bring questions about their own potential projects). The important points, needing monitoring and/or control, within a process stream will be examined and methods for their determination discussed.
We will also cover some of the hardware and software developed for PAT/QbD applications, including specific examples of successful applications. The course will cover at-line and in-line applications and how to generate and validate methods under cGMP rules. Included in the course will be Quality Risk Management (QRM) and Design of Experiment (DoE) approaches (with examples) for new products and conversion of legacy (batch) production to continuous manufacturing (CM).
Learning Objectives:
- Become familiar with FDA, EMA, and ICH Guidances
- Become familiar with the economic benefits of PAT, QbD, and CM: footprint (building savings), HVAC savings, warehouse savings (RM and intermediate storage), personnel savings
- Understand the economics and risks of converting legacy products from “normal” GMP to QbD controlled
- Discuss how to put a PAT/QbD committee in place; run meetings; set objectives/milestones; generate budgets
- Discuss how to pick the first product (candidate) for your first PAT/QbD project: economics, engineering difficulty, difficulty in production
- Learn what Design Space is and how to compute it properly and economically; discuss merits of available software
- Learn how Risk Management, Design of Experiments, and factors to monitor are related
- Understand terms such as CQA (critical quality attributes) and CPP (critical process parameter) and how to determine them
- Determine what monitors/controls are “necessary and sufficient”
- Discuss proper sampling techniques for process sampling
- Understand how to generate a sample set for calibration of on-line methods
- Learn how to construct and maintain a QbD equation (for the monitors: physical or spectroscopic)
- Understand how to validate and on-line analysis/control methods
Areas Covered:
- FDA, EMA, ICH Guidances
- Personnel needed for a successful program; departments and levels
- Building the team and setting goals and generating realistic budgets and timelines
- Software for Quality Risk Management (QRM), process control, and Design of Experiment (DoE)
- Technologies available for PAT/QbD: what they measure and what they can control
- Developing and validating process analysis methods
- Moving legacy products from GMP to QbD and, possibly, to CM
Who will benefit:
- Pharma and Biopharma production industries (proprietary companies, generic companies, and Contract Manufacturing Organizations (CMO))
- Production Engineers and Managers
- Analytical R&D Manager
- Analysts
- Formulators
- Quality Assurance/Compliance Managers and Analysts
- General Managers
- Statisticians/Chemometricians.
- 8:30 - 9:00 Registration
- 9:00 - 9:15 Introduction and Course Overview
- 9:15-11:00 Review of Guidances and Guidelines
- Critical Path Initiative
- USFDA’s PAT Guidance
- EMA’s PAT Mandate
- 21st Century Initiative
- ICH Guidlines
- Q8 Pharmaceutical Development
- Q9 Quality Risk Management
- Q10 Pharmaceutical Quality Systems
- Q11 Development and Manufacture of Drug Substances
- Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle
- US FDA Process Validation Guidance
- FDA and EMA NIR Guidelines
- 11:00-11:15 Break
- 11:15-12:30 Risk Assessment, Design of Experiment:
- Example: “Factors Affecting Inhaled Insulin Production”
- 12:30-1:30 Lunch
- 1:30-2:45 Examination of Tools needed/Used in PAT/QbD.
- UV/Vis spectroscopy
- Fluorescence
- “Conventional”
- Light-Induced Fluorescence (LIF)
- Near-Infrared Spectroscopy
- Raman
- Portable, benchtop
- “Gated” for fluorescence suppression
- Acoustics
- LASER-Induced Breakdown Spectroscopy
- NMR
- Less common technologies
- 2:45-3:30 Example: “Validation of a NIR Transmission method for tablets”
- 3:30-3:45 Break
- 3:45-4:45 (Cont’d) PAT/QbD applications of above instrumentation with examples
- Hardness via TeraHertz spectroscopy
- Cleaning validation via Ion Mobility Spectroscopy
- Packaging uniformity and ID validation with Chemical Imaging
- Process tablet uniformity with LIF
- 4:45 - 5:00 Wrap-up and questions/suggestions for Day 2
- 5:00 End of Day’s Workshop
- 09:00 Design of Experiment: (Software and experimental conditions)
- Example: “Tablet Formulation via DoE”
- 09:00-10:45 Break
- 10:45-11:00 Question based Review (QbR) Guidance/Rules
- Brief review of new rules for API and Stability requirements
- 11:00-11:30 Biopharmaceutical Applications of PAT/QbD:
- Example: “NIRS Monitoring an in-situ CHO Cell Culture Reaction”
- 11:30-12:00 Practical Application of PAT to Blend Uniformity
- Example: “NIRS vs. Sample Thief Sampling”
- 12:00-12:30 Lunch
- 12:30-1:30 Scale-up, using PAT principles
- 1:30-2:30 Continuous Manufacturing Equipment: PAT/QbD in continuous form:
- University set-up (Rutgers)
- Commercially available pilot plant
- 2:30-3:30 Break
- 3:30-3:45 Example of (FDA-approved) CM:
- “Vertex’s Ivacaftor Monotherapy and (combo) VX-809 + Ivacaftor for cystic fibrosis”
- 3:45-4:45 Wrap-up/questions
- 5:00 End of Workshop
Emil Ciurczak
President, Doramaxx Consulting
Emil W. Ciurczak, founder of Doramaxx Consulting, has almost 50 years’ experience in the pharmaceutical industry, performing method development. He has worked on pre-formulation studies, pilot plant scale-ups, as well as final product and stability indicating assay development. In 1983, he intro-duced NIRS to pharmaceutical applications (initially, for raw materials qualification). He was the first to report on polymorphism, optical isomer purity, blend uniformity, and particle size measured by NIRS. He has consulted for several NIR instrument companies, has published over seventy-five articles in refereed journals, over 300 magazine columns, and presented nearly 250 technical papers.
He is Contributing Editor for Pharmaceutical Manufacturing and Contract Pharma magazines, has written several texts and chapters on NIR applications to life sciences: “Handbook of NIR Analysis” (1st, 2nd, and 3rd ed. 4th in press), “Pharmaceutical and Medical Applications of NIRS” (1st and 2nd ed.), “Molecular Spectroscopy Workbench,” and numerous chapters. Emil is a consultant in the field of NIR and holds patents for NIR-based devices and software. He consults with pharmaceutical companies, instrument manufacturers, the FDA (PAT sub-committee, Validation), and works with the USP spectroscopy Expert group.
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