Date: 03 February 2012
Link FDA 483 (New Window)
ObservationAlthough this observation does not directly relate to 21CFR211.68 for computerised systems it still has an impact on the validation requirements of an automated system within a tablet manufacturing and packing line.
4. Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to
Link FDA 483 (New Window)
ObservationAlthough this observation does not directly relate to 21CFR211.68 for computerised systems it still has an impact on the validation requirements of an automated system within a tablet manufacturing and packing line.
4. Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to