FILLING OF BMR DOCUMENTS SOP


1.0   PURPOSE

It is established to provide proper filling of BMR in Capsule section.

2.0  SCOPE

This procedure is applied to filling & completion of B.P.O. & B.M.O. documents for final yield and reconciliation.

3.0  RESPONSIBILITY

Ø  Production Supervisor
Ø  Production  Manager
Ø  Production Pharmacist

4.0   PROCEDURE

4.1.      Batch Manufacturing Order – (B.M.O.)

Ø Take the Blank Set of Batch Mfg. Order.
Ø Enter the information i.e. Batch No. GRN and quantities of all items in the respective columns of B.M.O.
Ø After issuance Production and Raw Material Store Supervisor will put the signatures on B.M.O.
Ø After completion of batch, enter the quantities i.e. add issue, return, actual used and wastage in the respective columns on B.M.O. for conciliation.
Ø Calculate the Batch yield.
Ø After completion, send the copies to QC, Accounts and Inventory Control Department for record and costing.
Ø Send along with B.M.O. all the in Process documents to QC as listed on the envelop.

4.2.      Batch Packaging Order (B.P.O.)

Ø  Take the blank set of B.P.O.
Ø  Enter Batch No., GRN No. and quantity in the B.P.O. for issuance.
Ø  After completion of Batch, quantities and Stock Transfer No. are recorded on B.P.O.
Ø  B.P.O. is then reconciliated to calculate Batch yield and wastage of packaging components.
Ø  Submit inprocess checklist, line clearance certificate, S.T.T., stamps and approved samples of carton, label, leaflet and inner pack to QC for Batch History Record.
Ø  Production Supervisor will put signature on B.P.O. + envelop and submit to QC for review, final release and to keep B.P.O. for Batch History Record.
Ø  Submit copies of B.P.O. to QC Accounts and Inventory Control Department.

5.0   QUALITY FORMS AND RECORDS

After complete the BHR to submitted the Q.C records

6.0   DISTRIBUTION

Ø  Head of Operation
Ø  Q.A Manager
Ø  Production Manager
Ø  Q.C Manager
Ø  Production Pharmacist

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