PHRM07006 2013 PHARMACEUTICAL MANUFACTURING

Demonstrate competence in the application of a range of organic chemical synthetic techniques to the production of some common active pharmaceutical ingredients.

Generate and interpret standard preformulation data on some active pharmaceutical ingredients.

Propose and prepare appropriate pharmaceutical formulation based on end use and prefromulation data.

Investigate the effects of processing and packaging on pharmaceutical product manufacture.

Source and apply some relevant compendial tests and specifications for QC of conventional dosage forms.

Perform qualitative and quantitative laboratory analyses using e.g. HPLC, GC, IC, GCMS, UV and IR

Record, evaluate, interpret, and report on processing and analytical QC data at all stages with due consideration of cGMP

Generate and follow Standard Operating procedures (SOP's) in the execution of key manufacturing and QC processes. 

This is an integrated module which combines aspects of API synthesis and formulation along with product processing and analysis.

Practical sessions will include,

Generation of Standard Operating Procedures (SOP's)

Active Pharmaceutical Ingredient (API) synthesis

QC of API's using compendial methods and microbiological techniques

Product Formulation

QC of finished product using compendial and other methods:

Emphasis on chromatographic techniques for quantitative and qualitative analysis particularly HPLC 

• Practical aspects of HPLC analysis
• System suitability requirements
• Data interpretation and reporting
• Sample preparation (API vs Finished Product)

Emphasis throughout is on awareness of GMP / GLP requirements in a pharmaceutical environment.