Академический Документы
Профессиональный Документы
Культура Документы
AND INTERMEDIATES
Overview
• Introduction
• Scope
• Responsibilities
• The Requirements
General Considerations
Prevention of Cross-Contamination
Batch Manufacturing Records
And the others (13 items)
Introduction
• Manufacture of active pharmaceutical ingredients
(APIs) and intermediates as finished product, must
follow well-defined operating principles
*We have a separate guidance document which goes into detail on Water: Type, Production, Distribution,
Use & Storage and Operations and Control of Water Systems.
4. 12. Recovery of Materials &
Solvents
• Recovered materials and solvents must be recycled
and tested to pre-defined specifications according to
site procedures and in compliance with registration
dossiers
Any Questions