Tablet Process Development, Validation and the application of QbD

Venue: Window Conference Venue, Islington London UK

Location: London, United Kingdom

Event Date/Time: Nov 23, 2009 End Date/Time: Nov 24, 2009
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Course objectives

The goal of this workshop is to provide detailed information on the implications of Quality by Design (QbD) for the validation and qualification of tablet manufacturing processes and process development. We will also review the principles of PAT for tablets and capsules and their implications for process control, and introduce important new concepts including the use of risk and process matrices for risk management

By the end of the course, you will

* Understand the relationship between QbD principles and tablet development and process validation
* Understand the processes commonly used to manufacture tablets and capsules, and the factors which affect them
* Recognise how to identify critical processing parameters, and how to incorporate into a process validation program
* Understand the principles of PAT, how and where it can be most effectively deployed

Who should attend

Tablet formulation and process development staff and those involved in managing process development and validation, and commissioning products into production. Regulatory Affairs staff preparing dossiers for tablet products. Quality Assurance personnel responsible for the design or implementation of tablet process validation protocols. Numbers will be limited to give participants the opportunity for thorough discussion of the issues to be covered by the programme and one on one consultation with speakers.

Course speaker
Dr Michael Gamlen


Day 1

08.30 Registration and Coffee

09.00 Workshop Introduction

09.20 Regulatory aspect of product development

o ICH Guidance Q8, Q9 and Q10 - implications and impact
o EU GMP Requirements Part 1 and Annexe 20
o FDA guidance on process validation
o Applying the guidance in process development and validation

10.45 Morning refreshments

11.15 Quality by Design - the EUFEPS case study

o The six stage model of Quality by Design
o How these stages are identified and used in practice
o Applying the model to preformulation, formulation, process development and process validation studies

12.15 Discussion

o Review and Q&A

12.45 Lunch

14.00 Tablet development in practice

o Principles of formulation development
o M aterial and product characterisation
o Developing stable processes

14.45 Key unit processes (1)

o Mixing and blending
o Dry granulation

15.30 Afternoon refreshments

16.00 Blend uniformity assessment

We follow the development of a formulation from hand filled capsules to production tablet manufacture, reviewing blending options and actual results.

Sampling for accurate results

Why is it so difficult to get an accurate sample and what should you do to achieve this?

FDA Guidance on Blend Uniformity Testing

17.30 End of Day

Day 2

9.00 Case study - granulation end-point control

o Granulation - what and why
o Methods of granulation
o Granulation process control
o Case history - developing a self-controlling process

10.00 Key manufacturing processes (2)

o Drying
o Sieving

11.00 Morning refreshments

11.30 Key manufacturing processes (3)

o Tablet compression
o Film coating

12.00 Wet granulation scale up

o Effect of scale on key product attributes
o Implications for product quality and control systems

12.30 Lunch

14.00 Principles of process control and the application PAT

o What is PAT?
o Which analytical techniques can be used? What do they measure?
o On-line vs at-line

15.00 Afternoon refreshments

15.30 PAT case studies

o Use of NIR
o Use of Raman Spectroscopy
o Online monitoring of particle size

16.30 Closing Q&A

17.00 Course closes