This module provides the students with a comprehensive understanding of all aspects of Process Validation with respect to non-sterile Primary and Secondary Pharmaceutical Manufacture
The topics covered in the module include the manufacture of common non–sterile Primary (Drug Susbtance) and Secondary Pharmaceuticals (Drug Products) and the validation of these processes
· Pharmaceutical Technology relating to Primary Pharmaceutials
· Batch Organic Chemical Synthesis - Chemical Reactions and
Separation Technologies
· Reactor Configuration and Operation
· Buildings and facilities layout, and process equipment
· HVAC for Non-Sterile API Manufacturing
· Regulatory requirements for Primary and Secondary Pharmaceutical
Manufacture
· Pharmaceutical Technology relating to Secondary/Finished
Pharmaceuticals Granulation Milling,Compression Mixing/blending
- § Tabletting
- § Coating
- § Liquids
- § Semisolids
Aerosols §
Other finished product technologies ·
Prevalidation requirements scale-up studies, trial batches and process optimization, process transfer V new process, for Primary and Secondary pharmaceuticals ·
Impurity profiles and physical characteristics of API ·
Impact and risk assessment of primary and secondary manufacturing pharmaceutical processes ·
Control of primary and secondary manufacturing processes · Critical process parameters and quality attributes · Validation of re-working/reprocessing ·
Relationship between bulk pharmaceutical chemicals (BPC) and active pharmaceutical ingredients (API) ·
When to apply cGMPs to APls ·
Regulatory history of, and future for, Pharmaceutical manufacturing · Guidance for non-sterile process validation
Webinars, Class Discussion, Discussion Board, On-line videos,
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |