Prepared by Production: Approved by QA/QC:: TERASOL® 600 Bolus
Prepared by Production: Approved by QA/QC:: TERASOL® 600 Bolus
Prepared by Production: Approved by QA/QC:: TERASOL® 600 Bolus
NATIONAL
VETERINARY INSTITUTE
Final BMR checked By Production: ____________________ Final BMR checked by QA: ____________________
Safety precautions to be taken against explosions in Fluidized Bed Drier & while grinding.
Store the granules & tablets in well closed containers lined with double polythene bags.
Notes:
4. All equipments and machineries must be adequately guarded and earthed. The operators must use proper safety equipments
like hand gloves, nose masks, ear muffs, etc. during all operations.
5. Ensure that general cleaning & utensils cleaning are carried out as per respective S.C.P. & checked for cleanliness before use.
6. Ensure that RMG, Octagonal Blender, oscilating granulator, Vibratory sifter, S.S. Sieves, S.S., FBD, Screens, Compression
machine & tools and accessories etc. are cleaned as per respective S.C.P.
8. Batch size may be varied, depending upon the requirement. Prior permission of QC/QA should be obtained except in case of
batches in which reworking is added.
9. All the ingredients must have been passed by Q.C. Dept., prior to use and must be within retest date.
10.Destroy all rejected material & tablets by putting in a container of water after recording the weights.
- Check the dispensing area is cleaned and make assured the cleanliness by IPQA
- Make sure that all materials from previous operations have been removed
- Check the equipment and accessories from previous operations have been removed
- Make sure the paperwork from previous operations has been removed
- Check the status labels from previous operations have been removed
- Make sure the reverse laminar flow dispensing booths and surrounding area is cleaned &
Status is displayed
- Assure all the equipment & accessories required for dispensing are clean & labeled as
such.
S.n Ingredients A.R.No. Qty/bolus Qty/batch Tare Gross Net Weighed Checked
(mg) (kg) wt wt wt by by
1 Tetramisole Hcl
2 Maize starch
3 Dicalcium Phosphate
4 Red color
5 Sodium starch glycolate
6 HPMC 15 mpass
7 Mg. stearate
8 Colloidal silicon dioxide
Requisition given Cleanliness checked Issued by:________________
by:______________________________ by:________________________
Date________________
Date:______________ Date:______________
Checked by:_______________________ Cleanliness verified by:________ Received by:________________
Date:___________________________ Date:______________ Date__________________
- All materials and residues from previous operations have been removed.
5 Sizing process
Previous product____________________
Batch No._________________________
Area clearance & opening by production & QA
5.1 Check the integrity and intactness of the sieve before use.
5.2 Pass the dried granule and grind the coarse material through the
oscilating granulator using 2mm screen/sieve downward direction
oscilating forth & back of the roller of the oscilating granulator.
5.3 Collect the granule from the discharge port of the machine using isolated
containers by sealing the port by polyethylene to protect dust, wastage
generation and for safety.
6 Blending process
Previous product____________________
Batch No._________________________
Area clearance & opening by production & QA
6.1 Reworking
The total qty. of reworking added should not exceed 3% of the batch qty.
The reworking to be added should be crushed through 2mm screen/sieve
using oscilating granulator. Add the reworking to the bulk of blending.
Container Gross wt. (kg) Tare wt. (kg) Net wt.(kg) Weighed Checked by Date
by
1
2
3
4
5
6
7
8
9
Total
7.3 Proceed the compression process if the IPQA allow you to do so.
Description of the bolus Red coloured, oval tablet with breaking line embossing on one side
Machine used
Punches and dies ……..mm oval, break line on one side
Setting of the machine and Checking
of complete rotation By:………………………………… Checked by………………………….
commencement Date ……………………….. time ………………….
completion Date ……………………….. time ………………….
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11
12
13
14
15
Max. Wt. Allowed
Actual
Min. Wt. Allowed
Actual
8
9.
10.
11.
Total wt. in kg:__________ No. of Boli:_________
(Actual yield)
Reworking generated:………………………kg
PACKAGING
Check the blistering room, blistering machine, strip packing room, strip packing machine, code printing
areas, the manual packing room and any apparatus used for packaging. Following to checking tick
operations/observations (√) which are ACCEPTABLE and put (N/A) against any operations/observations
which are NOT APPLICABLE.
1 Assure all materials & residues of the previous operations have been removed
and check the blistering/strip packing room is clean and status is displayed
2 Check the blistering/strip packing machine is clean and status is displayed
3 Check the base foil splicing station and surrounding area
4 Check hopper and surrounding ledges including ladder
5 Check the forming area, surrounding ledges & cables including opening the
door behind the forming station at the back of machine and checking the area
6 Check sealing station
7 Check bliter/strip coding block has been removed & dye/coding station is
clear.
8 Check perforation station and surrounding area
9 Check all ledges around and below the punching station area
10 Check the blister/strip eject chute & check around, below and inside
blister/strip eject chute
11 Check around & around the blister/strip transfer conveyor
12 Check floor area and machine supports around/front/back of the machine
13 Check the top of the machine
14 Check all containers/collectors/bowls/trays are clean
15 Check the manual packing room is clean
16 Check whether the packaging materials are enough for the batch
17 Ckeck the precoding of labels and printed packaging materials are examined &
verified
18 Check the precoding label & printed box specimen is attached
Sign.of Supervisor__________________________________
Checked by:____________________________________