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Primary and Secondary pharmaceutical production - Coggle Diagram
Primary and Secondary pharmaceutical production
Definitions
Active pharmaceutical ingredient (API)
substance that is pharmaceutically active
Excipients
substance that is pharmaceutically inert
Example
diluent
fillers
lubricants
disintergrants
Manufacture of Pharmaceuticals
Chemical synthesis
Primary manufacture
chemical reactions using chemicals
API
usually well defined, small molecules and chemically known
General Process
1) Chemical reaction
2) Crystallization
3) Filtration
4) Drying
5) Milling
Secondary Manufacture
transform API to final dossge form
General process (for tablets)
1) Sieving
2) Dispensing
3) mixing/granulating
4) Compression
5) Coating
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Primary manufacture
Manufacture API
Secondary Manufacture
Manufacture final dosage form
Biological synthesis
Primary manufacture
using biological means
use micro-organisms, living cells/ components
produce API (target protein)
larger molecules
General procedure
1) Fermentation
2) Solid-liquid separation
3) Purification
Contract Manufacturer
Part of manufacturing process is outsource to another manufacturer
Easier, more efficient to bring newer drug to the market
Requirements
Must comply with cGMP
evaluated by the contract giver
special consideration must be made on
x-contamination
traceability
Have approve contract stating the GMP responsibilities of each party
Subcontracting only allowed after contract giver prior evaluation & approval
Manufacturing & laboratory records to be kept at site of activity
made readily available
Contract giver must give approval to changes first
includes changes to
Process
equipment
Test Methods
Specifications
Other contractual requirements