FILLING OF BMR DOCUMENTS SOP

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