Posted by
Dawnrays Pharma on Monday, April 20, 2009 5:18:05 AM
Intrinsic features of APIs:
• Synthesis, fermentation, extraction, purification,
crystallisation…
• closed system located outside
• by-products
• Use for M.P. Manufacturing
• control depends on process and manufacturing
stage – IPC – impurity profile
• validation of critical processing steps
• potable water/purified water/WFI
• reprocessing: typical
• batch records for critical process steps
reviewed by the QC unit