TRILOCHAN AYURVEDA.

BATCH MANUFACTURING RECORD

PRODUCT NAME:- HARDE

Mfg.Prese.No.- 030
Master formula no.:- 30
Version no.:- Tablet
Batch size:- 150KG
Batch no.:- HD/0003 Page No.:-030
B.M.R No.:-030
Effective Date :- 29/09/2020
Dosage form:- 2 TAB
BMR Sr.No. 030
Shelf life:- 3 year

Batch started on. Batch completed on. Manufacturing Date. Expiry Date.
29/09/2020 05/10/2020 SEP/20 AUG/23

Ingredients Table for Dispensing.

Sr.No Name of ingredients Part used Claim/Tab. Qty./Batch

.
1. HARDE FRUIT TAB 150KG

GENERAL INSTRUCTION
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.

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. Printing machine SOP NO.
9. Induction wed SOP NO.
10. Packing SOP NO. 11

Step No.1 Equipment cleaning record for product changing

Format Approved By.

CHETAN SUTARIYA DR.MANSUKH MANGUKIYA

Head-Manufacturing Head-Quality Assurance

This record followed by SOP no.

Sr. Equipment Batch Cleaning Follow SOP Cleaning checked By.

No. no. no.
Done on Done by Pro.che. Q.A.che.
1. Weigh Balance HD/0003 Daya lal Tulsi kaka SOP NO. 8 chetan Dr.mansukh bhai
2. Pulveriser HD/0003 Daya lal Tulsi kaka SOP NO. 1 chetan Dr.mansukh bhai
3. Sifter/Sieves HD/0003 Daya lal Tulsi kaka SOP NO. 2 chetan Dr.mansukh bhai
4. Mass Mixer HD/0003 Daya lal Tulsi kaka SOP NO. 5 chetan Dr.mansukh bhai
5. Dryer HD/0003 Daya lal Tulsi kaka SOP NO. 3 chetan Dr.mansukh bhai
6. Granulator HD/0003 Daya lal Tulsi kaka SOP NO. 4 chetan Dr.mansukh bhai
7. Tablet punching HD/0003 Daya lal Tulsi kaka SOP NO. 6 chetan Dr.mansukh bhai
8. Printing machine HD/0003 Daya lal Tulsi kaka SOP NO. chetan Dr.mansukh bhai
9. Induction wed HD/0003 Daya lal Tulsi kaka SOP NO. chetan Dr.mansukh bhai
10. Packing HD/0003 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.

0001 29/09/2020 150KG

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

qty.kg Gross Tare Net by. date.
HARDE 150KG 150kg Tulshi bhai Chetan 29/09/2020

Date Start time Completed time Remarks

29/09/2020 10.00 am 10.15 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
29/09/2020 10.30 am 03.00 pm DAYABHAI TULSHI BHAI

Theoretical weight of the raw herbs 150 kg.

Actual weight of powder obtains 135 kg
%yield 15 kg.:
Total weight of dry powder transferred to _135kg_ 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

Water followed by R.O. water rinse.

Date Start time Completed Sifting done by Sifting Remarks

time checked by
30/09/2020 10.30am 02.30pm DAYABHAI TULSHI BHAI

Theoretical weight of the raw herbs 135 kg.

Actual weight of powder obtains 134 kg
%yield 1 kg.:

Total weight of dry powder transferred to _134kg_ 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
30/09/2020 03.00pm 05.30pm TULSHI BHAI CHETAN

Theoretical weight of the mixed powder ___134_________kg.

Actual weight of mixed powder obtains____134_________kg
%yield ___0_______.:
Total weight of dry powder transferred to ______134_______ department..
Step 7:- 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
31/09/2020 09.30am 3.00pm DAYABHAI TULSHIBHAI

Theoretical weight of the mixed powder ___134._________kg.

Actual weight of mixed powder obtains____134.500_________kg
%yield ___0_______.:
Total weight of dry powder transferred to ______134_______ department..

Step 8:- 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
01/10/2020 09.30am 04.30pm DAYABHAI TULSHIBHAI

Theoretical weight of the mixed powder ___134.kg.

Actual weight of mixed powder obtains____133.kg
%yield ___1_______.:
Total weight of tablet transferred to __133kg__ department
Step 9:- Printing machine

Date Start time Completed Printing Printing Remarks

time machine machine
done by checked by
02/10/2020 9.30am 12.30pm DAYABHAI HARESHBHAI

Step 10:- Induction wed

Date Start time Completed Induction wed Induction wed Remarks

time done by checked by
02/10/2020 1.30pm 4.00pm DAYA BHAI TULSHI BHAI

Step 11 :- Packing

Date Start time Completed Packing done Packing Remarks

time by checked by
03/10/2020 9.30am 5.30pm KALYAN BHAI TULSHI BHAI

Step 12 :- final packing details :

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

packed packed checked by.
05/10/2020 180 TAB 1444 BOTTAL 1444 BOTTAL 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 1 133 259920 0.66
2. Mixing
3. Pulveriser 15 10
4. Tablet 1 0.66
punching
5. Total loss 17kg 11.33

1. Non-recoverable rejection destroyed KG= 17

2. Good Tablet KG= 133
3. Total KG= 150

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