11.GMP
11.GMP
11.GMP
QUALITY MANUAL
S.O.P.
M.F.# Title:___________________________________________________
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6. Mix for 10 minutes with Sweep. Time started Checked by_______
Time finished Checked by_______
Sweep ON__________Checked by_______
Manufacturing Batch Record
Sampling/Bulk Storage
Take one aseptic micro sample and two 4 oz. test samples from each drum as it is
being filled. Record Net Weights:
Drum #1 Drum #2
Gross_________________kg Gross_________________kg
Tare__________________kg Tare__________________kg
Net___________________kg Net___________________kg
Scale Used______________________ kg Scale Used______________________ kg
Total Weight _kg Total Weight _kg
Weighed by_______________________kg Weighed by_______________________kg
Checked by_______________________kg Checked by_______________________kg
Date Time___________kg Date Time___________kg
Manufacturing Batch Record
Yield Determination/Sign Off
Yield:
Checked by_________________
If Yield is greater than 100% or less than 90% Production Supervisor will investigate
and justify.
Remarks ____________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
PRODUCTION DATE___________
QCDEPARTMENT QCDEPARTMENT
BEINGRETESTED REF
U SED/ REJECTED
MATER IAL/ PRODUCTNAME :………….. TESTINGDA
TE MATE RIAL/ PRODUCTNA
M E :…………..
BATCHN O . :………….. …………. BATCHN O. :…………..
S
U PPLIER/ PRINCIPLENA
M E :………….. S
A MPLINGBY QCTE STINGR EPORTNO :………….. S
IGN :… .....
QUANT IT
Y :………….. …………. TESTINGD O NEBY :………….. DATE :….....
QUALITY CONTROL RECORD
Record for each testing, assay result and release or
rejection of starting materials, intermediates, bulk and
finished product should be maintained.