Module Indicative Content |
Pharmaceutical process legislation
Introduce legislation and mandatory requirements for processing - current EU, FDA,HPRA and ICH
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Pharmaceutical Industry
Introduction to the pharmaceutical industry and the requirements for GMP and Quality systems related to processing. Quality systems will include Good documentation practice (GDP), laboratory out of specification (OOS) and change management.
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Pharmaceutical Process
Effect of chemical and physical properties of the products (API or finished) on the process - To include: Salt formation, particle size, powder flow, kinetics and thermodynamics
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Process validation
Process validation and validation master plan. Introduction to concept of Process Analytical technology (PAT)
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Practicals
Practicals will be carried out to reflect and support the material covered in lectures.
The practicals will include the determination of active ingredients in pharmaceutical preparations
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DKIT reserves the right to alter the nature and timings of assessment
Module Resources
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This module does not have any book resources |
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This module does not have any article/paper resources |
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Other Resources |
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website, Health Products regulatory authority
(HPRA),
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Website, Food and Drug Administration (FDA),
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Website, European Medicines Agency (EMA),
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website, 'International congress on
harmonisation' (ICH). http://www.ich.org,
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