Lroo

  1. Excel packing
    US64
  2. PIC Packing
    US44
  3. PAB Packing
    US34
  4. Glass Packing
    US54
  5. Exceed E3
    US87
  6. Titan
    US94
  7. Excel Filling
    US63
  8. Month  A-E
    Jan-May
  9. Month H
    June
  10. Month J,K,L
    July, August, September
  11. Month N
    October
  12. Month P
    November
  13. Month S
    December
  14. Red Y56-203
    0061517045
  15. Orange Y56-202
    0061519527
  16. Purple Y56-204
    0061513492
  17. Teal Robbins egg blue Y56-205
    0061519531
  18. Yellow Y56-207
    0061519533
  19. Olive green Y56-206
    0061519532
  20. Excel bag failure locationsImage Upload 1
  21. DEFINITIONS QC manual
    3.1. Deviation - Failure to perform one or more steps in the manner required by the applicableoperating procedure. This includes omission of required step(s), performance of operationsdifferently than required by procedure, and operation with parameters outside of tolerancesspecified in procedure.
  22. DEFINITIONS QC manual cont.
    Nonconformance - Failure of product batch / lot to meet its specifications and proceduraldeviations. Nonconformance may be detected by testing, or may occur as a consequence of adeviation.
  23. DEFINITIONS QC manual cont.
    Reinspection - Repeating an inspection process. 100% inspection may be performed as acorrection for a discrepancy to remove defective units.
  24. DEFINITIONS QC manual cont.
    Repackaging - Repeating a packaging operation using standard components and procedures.Applies to outer packages only, not primary containers.

     Reprocessing - Repeating one or more steps from the approved manufacturing process.3.7. Rework - New process steps, not part of the approved process, performed to salvagenonconforming product.

    Rework raises issues regarding validation of the new steps and anyrelated methods, compliance with NDA, and adequacy of existing process validation. Theseconcerns cannot be satisfactorily addressed within the Discrepancy Management System;therefore rework is not undertaken without approval through the Change Control process andissuance of appropriate procedures.
  25. Case Damage
    • Case 2-xxxx (L8000) was found damaged on the palletizer, a total a 12 or 24 units rejected and tossed.
    • Reviewed and verified by process control.
  26. DFU's manually
    DFU's Y36-002-123 / 0061512345 manually verified for production by process control.
  27. Sterilization tags  "error reading"
    J7Axxx (L88002) sterilization tags (C1) manually verified due to bar code scanner not reading information.

    Reviewed and verified by process control.
  28. NDC
    SAP
    LAF
    • National Drug Code
    • Systems Applications & Products
    • Label Accountability Form
  29. PTRA

    QCRV

    EBR
    Production Test Run Area

    Quality Control Release Verification

    Electronic Batch Records
  30. PO

    PQ

    MWO
    Process Order

    Process Qualifications

    Manufacturing Work Orders
  31. DMI

    DSMS
    Discrepancy Management Interim

    Discrepancy Management system
  32. C O R E
    • Customer Focus
    • Operational Excellence

    • Revenue Growth
    • Employee Commitment
  33. DMO
    Demand Maintenance Order
  34. PAB challenge
    • A-M unprinted
    • B-J printed
Author
dizzod
ID
354449
Card Set
Lroo
Description
RCVG locations
Updated