The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD).
Who Should Attend?·
- Newcomers to tablet formulation development and manufacturing
- Production operators who need a better understanding of their products and how they have been developed
- Analytical and QC staff who would benefit from understanding the tablet development and production process
- Experienced personnel in one area of product development who need a broader overview
- Project team members needing a broader insight into formulation development including preclinical, clinical, and project management representatives
- Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers. Regulatory agency staff requiring practical experience
Learning outcomes
- Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development
- Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and tablet compressibility
- Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development
Day 1 Theme - Quality by Design (QbD) - ICH Q8-10
- Material properties and their impact on processing.
- The role of excipients
8.30am
Registration and coffee/tea
9.00am
Welcome. Introductions. Plan for the day. Learning objectives for course
9.15am
Introduction to Quality by Design – a new pharmaceutical
manufacturing system. Regulatory guidance.
10.45am
Coffee break
11.00am
Drug substance properties and their impact on formulation development. Part 1 — physico-chemical properties
12.45pm
Lunch
1.45pm
Approaches to formulation development using QbD principles.
Manufacturing Process selection—applicability of wet granulation/roller compaction/direct compression. Unit processes 1— blending.
3.00pm
Tea break
3.15pm
Unit processes 2—granulation and drying. Factors affecting granulation and drying behaviour. Critical Process Parameters for these processes. Impact of powder properties on manufacturing behaviour
4.45pm Wrap up
5.00pm Close
Day 2 Theme - Formulating good products
9.00am
Consolidation. Plan for day. Learning objectives for day
9.15am
Powder and granule characterisation — advanced techniques.
Porosity, compressibility, surface area
Identifiying Critical Process Parameters and Critical Quality Attributes
- Blending
- Granulation
- Drying
- Lubrication
- Compression
Coffee break
10.45am
Principles of process development. FDA Process Validation Guidance 2011 and the impact of QbD
12.45pm
Lunch and travel to Yeoman House
2.00
pm
Practical—impact of material properties on bulk powder behaviour
- Flow
- Bulk density
- Compressibility
- Particle size and shape
Tea break
3.15pm
Wet Granulation and drying practical
Lubrication and compression practical
5.00pm
Close
Day 3—Theme – theory into practice
9.00am
Consolidation. Plan for day. Learning objectives for day
9.15pm
Dry Granulation practical
Lubrication and compression practical
PracticaDirect compression products
Impact of excipient selection, grades, and processing on critical tablet quality attributes—
- Compressibility
- Friability
- Disintegration
Lunch
1.45pm
Practical—Direct compression products
Impact of excipient selection, grades, and processing on critical tablet
quality attributes—
- Compressibility
- Friability
- Disintegration
5.00pm - Depart
