Validation of sterile manufacturing process by media fill validation as per PICS guidelines for aseptic processing.
1.0 OBJECTIVE1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment.
5.0 REFERENCE (S)
6.1 EXIT AND ENTRY PROCEDURE
6.2 AMPOULE FILLING MEDIA
6.3 VIAL FILLING MEDIA:
6.4 ADVERSE CONDITIONS: (AMPULE/ VIAL)
6.5 STORAGE OF FILLING UNITS (AMPULE/VIAL)
6.7 DESTRUCTION OF MEDIA:
6.8 FREQUENCY OF MEDIA FILLS (AMPULE/VIAL):
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