Formulation & Processing Part 2 - QP Module

Monday, 09 March 2015

Formulation & Processing Part 2 - QP Module

Monday, 09 March 2015 08:30 - Friday, 13 March 2015 15:00 (GMT)

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Once ​a ​new ​chemical ​entity ​has ​proved ​its ​potential ​in ​clinical ​studies, ​the ​challenge ​begins ​to ​formulate ​the ​compound ​into ​an ​effective ​medicine ​and ​to ​manufacture ​that ​medicine ​reliably ​so ​that ​safety, ​quality ​and ​efficacy ​are ​assured.

This ​module ​addresses ​the ​two ​important ​activities ​of ​formulation ​and ​processing ​and ​provides ​key ​information ​on…

How ​the ​physico-chemical ​attributes ​of ​the ​drug ​and ​the ​therapeutic ​indication ​influence:
route ​of ​administration
dosage ​form
Assuring ​bioavailability
Methods ​of ​manufacture ​of ​the ​major ​dosage ​forms
Factors ​affecting ​suitability ​for ​use ​of ​the ​major ​dosage ​forms
The ​Qualified ​Person, ​and ​other ​key ​technical ​personnel, ​MUST ​have ​a ​detailed ​understanding ​of ​these ​topics ​if ​they ​are ​to…

Assist ​in ​the ​design ​and ​implementation ​of ​relevant, ​effective ​quality ​systems ​for ​dosage ​form ​manufacture
Contribute ​to ​the ​RISK ​ASSESSMENT ​process ​for ​processing ​changes ​and ​unplanned ​deviations
Assess ​the ​adequacy ​of ​cleaning ​strategies
Assess ​the ​potential ​impact ​of ​changes ​to ​physical ​and ​chemical ​attributes ​of ​starting ​materials
This, ​therefore, ​represents ​one ​of ​the ​key ​modules ​in ​this ​series.
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