Sterile Monographed Waters
Sterile Monographed Waters The following monographed waters are packaged forms of either Purified Water or Water for Injection that have been sterilized
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VOLUMETRIC APPARATUS
Most of the volumetric apparatus available in the United States are calibrated at 20°, and the National Institute of Standards and Technology NIST has
Pure Steam
Pure Steam— is also sometimes referred to as “clean steam”. It is used where the steam or its condensate would directly contact official articles or
General
Water for Hemodialysis
Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
General
Water for Injection
WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled
Purified Water Monograph
Purified Water Note—For microbiological guidance, see USP general information chapter Water for Pharmaceutical Purposes 1231. H2O 18.02 DEFINITION
General
Purified Water [PW]
PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.
General
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
Periodic Review and Requalification
Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained
QA
Performance Qualification (PQ): Protocol, Steps & Examples
To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
QA
Operational Qualification (OQ): Protocol, Tests & Examples
Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.