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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