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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