IMPORTANCE OF WATER
¨Water is widely used as a raw material, ingredient and solvent in the processing formulation and in the manufacture of pharmaceutical products, Active pharmaceutical ingredients and in intermediates.
¨There is no single specification as it would unnecessarily burden some users with irrelevant specifications
¨Water systems need to be operated and maintained in a controlled manner that requires the system to be validated as certain analysis like microbial analysis needs time.
Water quality
¨Product requirements
¨Dosage form
¨Usage(Production or cleaning)
¨Internal quality
¨Regulatory requirements
Use point criteria
¨Delivery pressure and temperature
¨Delivery flow rate
¨Utilization schedule
¨Level of automation
System criteria
¨Storage
¨Feed water quality
¨Generation rate
¨Existing capacity
¨Cost factors
