Sr. No.
Responsibilities
1.0
Issuance and Retrieval of Log Book and Loose Annex.
1.1
Issuance and Retrieval of Log book as per request given by concern department.
1.2
Issuance and Retrieval of Loose Annex as per request given by concern Department.
2.0
Batch No allocation.
2.1
Batch No assign (allocate) as per production planning given by Production department check required detail (i.e. Product name, brand name, SFG code, FG code Mfg date and Exp date etc) in “BMR/BPR Issuance Requisition” and assign (allocate) the batch no.
2.2
Verification of BMR/BPR Issuance Requisition after allocation of batch Number.
3.0
Issuance and Retrieval of BMR and BPR.
3.1
Arrange the photocopy of BMR/BPR from master copy and write down Batch number along with department wise Batch record checklists with Accountability check list for Batch Manufacturing and Batch Packing records same shall be recorded in BMR/BPR issuance register.
3.2
In case of process validation/Optimization/Stability Batches stamp as per intimation provide by concern and same shall recorded in BMR/BPR issuance register.
3.3
Retrieval of BMR and BPR from IPQA after review and batch released.
4.0
Document Master and controlling activity.
4.1
All document Master and controlled at Thol location same shall be Master and controlling and distribution as per SOP.
4.2
Allocation of Current SOP Number as per SOP
4.3
Update SOP index and take print of updated SOP index Master and distribution to concern department.
4.4
Check SOP as per standard SOP, check all required document before effective and prepare Master copy.
4.5
Concern activity related SOP preparation and review.
4.6
CQA document controlling and distribution as per SOP.
4.7
Disposition form for obsolete artwork controlling and distribution as per SOP.