TRILOCHAN AYURVEDA.

BATCH MANUFACTURING RECORD

PRODUCT NAME:- SITOPLADI.

Mfg.Prese.No.- 010 Batch no.:- ST/0001 Page No.:-010
Master formula no.:- 10 B.M.R No.:-010
Version no.:- Tablet Effective Date :- 2/1/19
Batch size:- 25.826kg Dosage form:- 2 TAB
BMR Sr.No. 010
Shelf life:- 3 year

Batch started on. Batch completed on. Manufacturing Date. Expiry Date.
2/1/19 7/1/19 JAN/19 DEC/21

Ingredients Table for Dispensing.

Sr.N Name of ingredients Part used Claim/Tab. Qty./Batch

o
1. SARKARA Extract TAB 13.330KG
2. VASKAPOOR Resin TAB 6.665KG
3. PIPAR Fruit TAB 3.332KG GENERAL
4. ELACHI Seed TAB 1.666KG INSTRUCTION
5. TAJ Bark TAB 0.833KG
FIRST AID MEASURES:-
1. In case of contact with skin and eye, flush with copious amount of water
2. Shift victim to fresh air
3. If wallowed and found necessary seek medical aid immediately

Format Approved By. Format Approved By.

CHETAN SUTARIYA DR.MANSUKH MANGUKIYA
Head-Manufacturing Head-Quality Assurance

GENERAL INSTRUCTION EXPOSURE CONTROL AND PERSONAL PROTECTION:-

1. Wear uniform hand gloves,masks,sleeper etc while working in production

2. Do not enter in production with long nails,beared,opened hair and contaminated nail
3. Do not enter in production with jewellery,wrist,watch,belt,and lather pocket and mobile phone
Do not enter in production with person having eye or mouth disease and having wound with
bleeding
4. Avoid unnecessary movement in manufacturing felling and packing area
 List of Equipment & Services.

Sr. Name of machines Respective SOP for

No. operating & cleaning
1. Weigh Balance (10Kg and 100Kg) SOP NO. 8
2. Pulveriser SOP NO. 1
3. Sifter/Sieves SOP NO. 2
4. Mass Mixer SOP NO. 5
5. Dryer SOP NO. 3
6. Granulator SOP NO. 4
7. Tablet punching SOP NO. 6
8. Packing SOP NO. 11

Step No.1 Equipment cleaning record for product changing

Format Prepared By. Format Approved By. CHETAN

SUTARIYA DR.MANSUKH MANGUKIYA
Head-Manufacturing Head-Quality Assurance

This record followed by SOP no.

Sr. Equipment Batch no. Cleaning Follow SOP Cleaning checked By.
No. no.
Done on Done by Pro.che. Q.A.che.
1. Weigh Balance ST/0001 Daya lal Tulsi kaka SOP NO. 8 Chetan Dr.mansukh bhai
2. Pulveriser ST/0001 Daya lal Tulsi kaka SOP NO. 1 Chetan Dr.mansukh bhai
3. Sifter/Sieves ST/0001 Daya lal Tulsi kaka SOP NO. 2 Chetan Dr.mansukh bhai
4. Mass Mixer ST/0001 Daya lal Tulsi kaka SOP NO. 5 Chetan Dr.mansukh bhai
5. Dryer ST/0001 Daya lal Tulsi kaka SOP NO. 3 Chetan Dr.mansukh bhai
6. Granulator ST/0001 Daya lal Tulsi kaka SOP NO. 4 Chetan Dr.mansukh bhai
7. Tablet punching ST/0001 Daya lal Tulsi kaka SOP NO. 6 Chetan Dr.mansukh bhai
8. Packing ST/0001 Daya lal Tulsi kaka SOP NO. 11 Chetan Dr.mansukh bhai

AREA: DISPESING
Step-1: Dispensing
Dispensing started on (Date):________________
 Check the balance at the zero position,
weigh all the ingredients accurately,
recheck the weights and raw materials control no. Of dispensed material as per raw material requisition.
Reference SOP No.:
For room temperature, relative humidity, equipment clearance and area clearance refer : area log Book
(Dispensing) for the corresponding day.

Good issue slip no. Date Weighing balance nos.

0010 2/1/19 25.826

Item Required Issued qty.kg Done by. Checked Verified by

qty.kg Gross Tare Net by. date.
SARKARA 13.330KG 13.330KG Tulshi bhai Chetan 2/1/19
VASKAPOOR 6.665KG 6.665KG Tulshi bhai Chetan 2/1/19
PIPAR 3.332KG 3.332KG Tulshi bhai Chetan 2/1/19
ELACHI 1.666KG 1.666KG Tulshi bhai Chetan 2/1/19
TAJ 0.833KG 0.833KG Tulshi bhai Chetan 2/1/19

Date Start time Completed time Remarks

2/1/19 09.30 am 11.30 am

Verification of batch assembly Assemble dispensed RM with lubricants in batch assembly room

Step 2:- Pulveriser

1. Pulveriser all materials.

2. Collect the pulveriser materials in a plastic container having cleaned status label.
3. When pulveriser is over, clean the pulveriser using air vacuum,

Date Start time Completed Pulveriser done Pulveriser Remarks

time by checked by
2/1/19 12.30 am 05.30 pm DAYABHAI TULSHI BHAI

Theoretical weight of the raw herbs 25.826 kg.

Actual weight of powder obtains 24.500kg
%yield 1.326kg.:
Total weight of dry powder transferred to 24.500_kg_ department..
Step 3:- Sifting of Materials

Line clearance is given by QA________________________________________

1. Sift all materials through 40# /60# mesh screen one by one.
2. Collect the sifted materials in a plastic container having cleaned status label.
3. Wash 20/60 mesh sieve with hot filtered water followed by 0.1% teepol & than again wash with
filtered
4. Check the integrity of the sieve before & after sifting of individual material.
5. Sift the material as per sequence & specified mesh sieves given.
6. Check for residue if any for each ingredient & replace the material
7. Retained over sieve with fresh material & record the wt.

Water followed by R.O. water rinse.

Date Start time Completed Sifting done by Sifting Remarks

time checked by
3/1/19 10.30am 03.00pm DAYABHAI TULSHI BHAI

Theoretical weight of the raw herbs 24.500kg.

Actual weight of powder obtains 24.300 kg
%yield 0.200kg.:

Total weight of dry powder transferred to _24.300kg_ department..

Step 4:- Mixing

Line clearance is given by QA________________________________________

1. Start to unload the materials into mixer as per sequence noted in MFR
run the mixer as per time stipulated in MFR for that particular product.
2. When mixing is over, clean the mixer using filtered water, teepol followed by rinse of R.O. water

Date Start time Completed Mixing done by Dry mixing Remarks

time checked by
3/1/19 03.30pm 06.00pm TULSHI BHAI CHETAN

ADD ACACIA GUM 0.200KG

Theoretical weight of the mixed powder __24.300kg.

Actual weight of mixed powder obtains__24.300kg

%yield ___0_______.:
Total weight of dry powder transferred to _24.300KG__ department..
 Step 5:- Granulator

1. Start to unload the materials into Granulator as per sequence noted in MFR
run the Granulator as per time stipulated in MFR for that particular product.
2. When Granulator is over, clean the Granulator using filtered water, teepol followed by rinse of R.O.
Water
3. Collect the Granulator materials in a plastic container having cleaned status label.

Date Start time Completed Granulator Granulator Remarks

time done by checked by
4/1/19 09.30am 4.00pm DAYABHAI TULSHIBHAI

ADD WATER 2.0LTR AND SANKHJIRU 0.200KG

Theoretical weight of the mixed powder __24.300kg.
Actual weight of mixed powder obtains__26.500kg.
%yield ___0_______.:
Total weight of dry powder transferred to ___26.500KG. department..

Step 6:- Dryer

1. Moisture content in the dry powder is measured as per SOP no._3
2. Moisture content of dry powder is ____% permissible limit : NMT 7%

Date Start time Completed Dryer done by Dryer checked Remarks

time by
4/1/19 04.30pm Tulshi bhai
5/1/19 11.30 Chetan bhai

Theoretical weight of the mixed powder ___26.500kg.

Actual weight of mixed powder obtains__26.kg
%yield __0.500KG__.:
Total weight of powder transferred to __26kg__ department

Step 6:- Tablet punching

1. Start to unload the materials into Tablet punching as per sequence noted in MFR
run the Tablet punching as per time stipulated in MFR for that particular product.
2. When Tablet punching is over, clean the Tablet punching using vacuum,
3. Collect the Tablet materials in a plastic container having cleaned status label.

Date Start time Completed Tablet Tablet Remarks

time punching done punching
by checked by
5/1/19 11.30am 06.30pm DAYABHAI TULSHIBHAI
 Theoretical weight of the mixed powder __26kg.
Actual weight of mixed powder obtains___25.500_.kg
%yield __0.500____.:
Total weight of tablet transferred to __25.500kg__ department

Step 7:- Printing machine

1. Starting of operation the labels and cartons are checked for any defect. Check identity of product &
Quantity of product before starting of packing operation.
2. Starting fresh batch all material required are brought and kept at relevant place only.

Date Start time Completed Printing Printing Remarks

time machine machine
done by checked by
6/1/19 9.30am 2.30pm DAYABHAI HARESHBHAI

Step 8:- Induction wed

Date Start time Completed Induction wed Induction wed Remarks
time done by checked by
6/1/19 2.30pm 5.00pm DAYA BHAI TULSHI BHAI

Step 9:- Packing

1. After packing is over, inform Q.A. for their check.
2. Deliver the goods to the warehouse only on receipt of final approval from Q.A.
3. Disposal of excess labels, cartons and records is done as per SOP No.12
4. Clean up the area at the end of days work.

Date Start time Completed Packing done Packing Remarks

time by checked by
7/1/19 9.30am 5.30pm KALYAN BHAI TULSHI BHAI

Step 10:- final packing details:

Date Pack size No of carton packed No of shippers Examined & Remarks

packed checked by.
7/1/19 60 TAB 830 830 CHETAN BHAI

Random sampling of packed goods by _____of Q.A department was found O.K/defective.
Total Qty. Transfer to finished goods store ___OK______
Total retain sample transfer to Q.A dept. With transfer slip ___OK_____
Total no. Of analytical sample given ___ 5_____
In process sample given ___ 5_____
Leak test sample given ____5____

Packing supervisor___Chetan bhai

YIELD RECONCILIATION:-
Format Prepared By. Format Approved By.
CHETAN SUTARIYA DR.MANSUKH MANGUKIYA
Head-Manufacturing Head-Quality Assurance

Sr.No. Loss Recovery Yield (GOOD TABLET)

during
process
(kg)
Process loss Qty.in kg No. of Tablet Kg No. of %Yield
during Tablet.
1. Sifting 0.200 25.500 50232
2. Mixing
3. Pulveriser 1.326
4. Tablet 0.600
punching
5. DRYER 0.500
6. Total loss 2.626

1. Non-recoverable rejection destroyed KG=2.626

1. Good Tablet KG= 25.500

Calculated by:- Checked by:-

Sing and Date Sing and Date

TRANSFER OF INPECTED TABLET TO THE PACKING DEPARTMENT

After release from QC department, transfer the checked tablet to packing department as per SOP for
transfer of tablet to packing Area (SOP No. :001)
Transferred by:-_______________ received by:-_________________
Sing and Date Sing and Date