 
INTRODUCTION
This 2 day course covers all aspects of design of facility, implementation of the required
controls, storage and supply of Tablets.
COURSE LEADER
Dr. Afshin Hosseiny - Bsc. Msc. Ph. D. C. Chem MRSC M.inst. Pkg www.tabrizconsulting.co.uk
- QA director for GlaxoSmithKline until April 2004
- QP via permanent provisions
- Has worked with manufacturers (primary and secondary, sterile and non-sterile), wholesalers and distribution centers across Western Europe, the Far East and the USA
- Detailed working knowledge of European and FDA validation requirements
- More than 15 years experience of preparation for and fronting of regulatory inspections.
Afshin has hands on experience on design and validation of filling and packing lines for products supplied to SA, he is a member of the UK standards committee for development of the ISO GMP standards for packaging components.
PROGRAMME
Introduction
- Defining the spectrum of products in this group
- Advantages and disadvantages of tablets for patients and manufacturers
- Drug absorption into body
- What influences the drug uptake
Tablet manufacturing process
- Selection of starting materials and their roles in the final product quality
- Granulation process
- Dry granulation
- Wet granulation
- Compression
- Film coating
Important quality characteristics of tablets - Workshop
- Defining key problems which affect tablet manufacturing
Regulatory expectations and GMP considerations for tablet manufacturing
- Facility design
- Equipment design
- Cleaning
- Personnel
- Starting materials
- Validation
- Records
- Cross contamination issues
Validation of the tablet granulation process - Workshop
- Validation plan
- Identifying critical parameters
- Execution
- Documentation and final reporting
The compression Process
- Compression machine set and maintenance
- Critical steps
- Identifying critical devices
- Preparing and testing critical devices
- In process control tests
Validation of the compression process - Workshop
- Planning for validation
- Identifying Critical steps
- Testing critical steps
- Sampling and monitoring
- Documentation and reporting
The film-coating process
- Film coating options
- Critical parameter in the process
- How to control and monitor critical parameters
Film coating validation - Workshop
- Planning for validation
- Identifying critical parameters
- Defining standards and monitoring
- Sampling and testing
- Documentation and reporting
Cleaning and cleaning validation
- Understanding the risks
- Air handling systems
- Multi product vs. dedicated facilities
- Validation planning and execution
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