‫شركة مصانع األدوية البيطرية والزراعية‬

VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING Co. Ltd

BATCH MANUFACTURING RECORD
Page 1 of 5
ENROSOL – S ORAL SOLUTION
Generic Name : Enrofloxacin Oral Solution Product Code: 32.2.035
Batch Size: 1500 Lt Supersedes: N/A
Document No: VT/ENS/A :Eff. Date

Issued By/ Date Checked By/ Date Received By/ Date :Batch No

:Mfg. Date

BILL OF RAW MATERIALS

Theoretical
Quantity to
Quantity Batch Dispensed Received
Material Name be Issued
Per Number By/Date By/Date
# /kg
Batch / kg
Enrofloxacin 150.00

otassium Hydroxide 45.000

Carboxy Methyl Cellulose 1.5000

Ethanol 96 15.000

Basonyl-Red 0.0600

Purified water 1500.0

QS : up to Total Volume *

Calculate the Quantity to be Issued based on the Active Ingredient Assay according to the following : #
Formula: Quantity of Active Ingredient to be issued / kg = Theoretical Quantity Per Batch / kg × 100
Actual Assay of Active Ingredient
..…………………………………………………………………………………………………………… :Remarks
..............................…………………………………………………………………………………………
..……………………………………………………………………………………………………………
..……………………………………………………………………………………………………………
..……………………………………………………………………………………………………………
..……………………………………………………………………………………………………………
..……………………………………………………………………………………………………………

Prepared Checked Approved By/Date

By/Date By QA/Date R&D VT PM QA
 ‫شركة مصانع األدوية البيطرية والزراعية‬
VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING Co. Ltd
BATCH MANUFACTURING RECORD
Page 2 of 5
Product: ENROSOL – S O.S Document No: VT/ENS/A Batch No:

Step
No MANUFACTURING PROCEDURE
Remarks :
1. Line clearance should be done before starting the activity.
2. Before using any ingredient, match its quantity and batch number with those written in Bill of
materials.
3. If any parameter is out of stated limits inform your supervisor.
4. Check the calibration status of relative equipment.

Preparation of Bulk Batch

1.0 Start time : ____:____ Date: ____ /_____ /______ Signature :________________
Ensure cleanliness and absence of materials not related to operation. Put signature and date when found
1.1 satisfactory
Checked By: / Date Verified By /Date
Thomson line Staging Room (VT-021) …………………… …………………
Thomson Liquid Preparation Room (VT-022) …………………… …………………
2500 Lt Mixing Tank (V/854/05) …………………… ……………....…
1500 Lt Mixing Tank (V/019/77) …………………… ……………....…
500 Lt Mixing Tank (V/159/88) …………………… ……………....…
Portable mixer (V/021/77) . …………………. ………………....
110 Lt Container (V/20/77) …………………… ……………....….

Record :
1.2 Previous Product Name ………………………………Batch No.:……………………

Recorded By/Date: ……………….. Checked By/Date: …..………….

Transfer all materials to Staging Area; Check all materials for identity and quantities against batch
1.3 documents.
1.4
Done By/Date: ………………….Checked By/Date: …………………

Transfer all materials to Mixing Room.

Done By/Date: ………………….Checked By/Date: …………………

Prepared Checked Approved By/Date

By/Date By/Date R&D VT PM QA
 ‫شركة مصانع األدوية البيطرية والزراعية‬
VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING Co. Ltd
BATCH MANUFACTURING RECORD
Page 3 of 5
Product: ENROSOL – S O.S Document No: VT/ENS/A Batch No:

Step
No MANUFACTURING PROCEDURE
Preparation of Solution A
1.4 Load the second portion of Purified Water (1000 Lt) in the 1500 Lt Mixing Tank, switch the mixer on
medium speed (6).

Done By/Date: ………………….Checked By/Date: …………………

1.5
Add the whole quantity of Potassium Hydroxide (45.0 kg) slowly in small portions, mix for 20
min. make sure that the material completely dissolved.

Mixing start time: ……….….Mixing end time: …………….Total mixing time………………

1.6
Done By/Date: ………………….Checked By/Date: …………………
Add the whole quantity of Enrofloxacin ( kg) slowly in small portions, increase mixing
1.7 speed to maximum (9), and mix for 20 min. make sure that the material completely dissolved.

Mixing start time: ……….….Mixing end time: …………….Total mixing time………………

1.8 Done By/Date: ………………….Checked By/Date: …………………

Preparation of Solution B
Load first portion of Purified Water (300.0 Lt) in the 500 Lt stainless steel Tank, switch the
Portable mixer above the tank.
1.9
Done By/Date: ………………….Checked By/Date: …………………
Add the whole quantity of Carboxy Methyl Cellulose (1.50 kg) slowly in small portions, keep
1.10 mixing for 60 min., and make sure that the material completely dissolved.

Mixing start time: ……….….Mixing end time: …………….Total mixing time………………

1.11 Done By/Date: ………………….Checked By/Date: …………………

Add Solution A to the above solution in the 1500 Lt Mixing Tank, keep mixing on maximum speed (9) for
30 min .make sure that the material completely dissolved.

Mixing start time: ……….….Mixing end time: …………….Total mixing time………………

Done By/Date: ………………….Checked By/Date: …………………

Prepared Checked Approved By/Date

By/Date By/Date R&D VT PM QA
 ‫شركة مصانع األدوية البيطرية والزراعية‬
VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING Co. Ltd
BATCH MANUFACTURING RECORD
Page 4 of 5
Product: ENROSOL – S O.S Document No: VT/ENS/A Batch No:

Step
No MANUFACTURING PROCEDURE

1.12 Preparation of Solution C

Load the whole quantity of Ethanol 96 % (15.0 kg) in the 110 Lt Containers.

Done By/Date: ………………….Checked By/Date: …………………

Add the whole quantity of Basonyl Red Dye (0.06 kg) the Ethanol 96 % in the 20 Lt Container,
1.13 mix manually using spatula for 5 min. make sure that the material completely dissolved.

Mixing start time: ……….….Mixing end time: …………….Total Mixing Time………………

Done By/Date: ………………….Checked By/Date: …………………

Add Solution C to the above Solution in the 1500 Lt Mixing Tank, keep mixing on maximum speed (9) for
1.14 5 min .make sure that the material completely dissolved.

Mixing start time: ……….….Mixing end time: …………….Total Mixing Time………………

Done By/Date: ………………….Checked By/Date: …………………

2.0 Complete the volume up to total volume 1500 Lt with purified water, keep mixing on maximum
speed (9) for 10 min, and make sure that the solution is homogeneous.

Done By/Date: ………………….Checked By/Date: …………………

Contact QA for sampling
QC samples quantity: …….…….
Sample taken By/ Date: …………….

Yield Calculation :
Calculate the manufacturing accountability and yield in the Batch Manufacturing Yield and
Accountability
Finish time : ____:____ Date: ____ /_____ /______ Signature :________________

Stage checked by Production: ……………Date: …………Verified by QA: …………..Date: ………….

Prepared Checked Approved By/Date

By/Date By/Date R&D VT PM QA
 ‫شركة مصانع األدوية البيطرية والزراعية‬
VETERINARY & AGRICULTURAL PRODUCTS MANUFACTURING Co. Ltd
Batch Manufacturing Yield and Accountability Page 5 of 5
Product: ENROSOL – S O.S Document No: VT/ENS/A Batch No:
Sampling Details (To be recorded in Volume/Lt) Batch Size: ………………… 1.0
Details of Sample Production Recorded QA Recorded QC Recorded R&D Recorded Total Recorded
by/Date by/Date by/Date by/Date by/Date
Bulk

Total (A) Recorded by/Date

2.0Leftover and Rejection Details (To be recorded in Volume/Lt)

Stage Quantity Signature Date
Bulk Manufacturing

Total (B) Recorded by/Date

Accountability (To be recorded in Volume/Lt) 3.0

Number Signature Date
Sample Quantity (A)
Leftover / Rejection Quantity (B)
Bulk Quantity for Packing (C)
% Yield Yield = C/ Batch Size x100%
Accountability % Accountability = (A+B+C+)/Batch Size x100%
………………… :Checked By Production / Date: ………………….. Reviewed By QA/Date
Prepared By/Date Checked By QA/ Date Approved By/Date
R&D VT PM QA