QCS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 126

SOP No.:

Issued on:

Revision No.:

Initiator name:

annexure viii
QUALITY ASSURANCE DEPARTMENT
BATCH DOCUMENTS CHECKLIST

Product:

Code No.: Mfg.:

Batch No.: Expiry :

documents dept. yes no n/a remarks

1. Packaging report and release of finished product
(different consignees)

Packaging

2. QC analytical report of finished product (different
consignees)

QC

3. Finished product checklist QA

4. Inspection start-up checklist with release labels (each
consignee)

QA

5. In-process filling chart for tablet and capsules/liquids/
PPS/cream and ointment/sachets/supp.

QA

6. Final packaging record (for different consignees) QA

7. Documents compliance declaration Packaging

8. Checklist for batch documents audit Packaging

9. Batch packaging record No. 1/addendum BPR Packaging

10. Time sheets (1st shift and 2nd shift) for different
lines

Packaging

11. Batch packaging record for blisters/liquids/
ointments and creams/supp./PPS

Packaging

12. Batch packaging record for bottle torque Packaging

13. Batch packaging record for hand packing Packaging

14. Reconciliation form for labels (all consignees) Packaging

15. First and last signed label from each used label roll
available

Packaging

16. Reconciliation form for boxes (all consignees) Packaging

17. Reconciliation form for aluminum/PVC (printed/
coded) (all consignees)

Packaging