Aseptic Pharmaceutical Production Facility
cGMP current Good Manufacturing Practices
HEPA High Efficiency Particular Air
QA Quality Assurance
QC Quality Control
PW Purified Water
USP United States Pharmacopeia
sWFI Sterilized Water for Injection
BieX Pharmaceuticals is producing a new process of dissolution of a dry Active Pharmaceutical Ingredient (API) in sterilized Water for Injection (sWFI). The resulting solution will be filled in the similar volume containers and then terminally sterilized.
The manufacturing will comply with all cGMP guidelines. The sterilization procedure will comply with relevant specifications to ensure that no pyrogens or bacterial endotoxins are present. The final dosage form should be free of particulates.
The facility will Continue reading...