TRILOCHAN AYURVEDA.

BATCH MANUFACTURING RECORD

PRODUCT NAME:- SAMSHAMANI TAB

Mfg.Prese.No.- 015 Batch no.:- SI/001 Page No.:-0015
Master formula no.:- 15 B.M.R No.:-0015
Version no.:- Tablet Effective Date :- 22/7/20
Batch size:- 100KG Dosage form:- 2 TAB
BMR Sr.No. 0014
Shelf life:- 3 year

Batch started on. Batch completed on. Manufacturing Date. Expiry Date.
22/7/20 26/07/20 JUL/20 JUN/23

Ingredients Table for Dispensing.

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

o
1. SAMSHAMANI POWDER TAB 100KG

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. 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 SI/001 Daya lal Tulsi kaka SOP NO. 8 Chetan Dr.mansukh bhai
2. Pulveriser SI/001 Daya lal Tulsi kaka SOP NO. 1 Chetan Dr.mansukh bhai
3. Sifter/Sieves SI/001 Daya lal Tulsi kaka SOP NO. 2 Chetan Dr.mansukh bhai
4. Mass Mixer SI/001 Daya lal Tulsi kaka SOP NO. 5 Chetan Dr.mansukh bhai
5. Dryer SI/001 Daya lal Tulsi kaka SOP NO. 3 Chetan Dr.mansukh bhai
6. Granulator SI/001 Daya lal Tulsi kaka SOP NO. 4 Chetan Dr.mansukh bhai
7. Tablet punching SI/001 Daya lal Tulsi kaka SOP NO. 6 Chetan Dr.mansukh bhai
8. Packing SI/001 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.

0015 10/5/20 100KG

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

qty.kg Gross Tare Net by. date.
GILOY 100KG 100KG Tulshi bhai Chetan 22/7/20

Date Start time Completed time Remarks

22/07/20 09.30 am 11.30

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

Step 2:- 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
22/07/20 11.30pm 03.00pm TULSHI BHAI CHETAN

ADD ACACIA GUM 10 KG

Theoretical weight of the mixed powder ___110_________kg.

Actual weight of mixed powder obtains_____110__kg
%yield ___0_______.:
Total weight of dry powder transferred to 110 KG 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
23/7/20 09.30am 4.00pm DAYABHAI TULSHIBHAI

ADD WATER 8.LTR AND SANKHJIRU 2 KG

Theoretical weight of the mixed powder ___112__kg.
Actual weight of mixed powder obtains___112 kg
%yield ___0_______.:
Total weight of dry powder transferred to 112 KG 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
23/07/20 04.30pm Tulshi bhai
24/07/20 11.30 Chetan bhai

Theoretical weight of the mixed powder ___104 kg.

Actual weight of mixed powder obtains__104 .kg
%yield ____.:
Total weight of powder transferred to __104 kg__ 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
 24/07/20 11.30am 06.30pm DAYABHAI TULSHIBHAI

Theoretical weight of the mixed powder ___101 kg.

Actual weight of mixed powder obtains___101_.kg
%yield __3KG_____.:
Total weight of tablet transferred to __101 kg__ 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
25/07/20 9.30am 5.30pm DAYABHAI HARESHBHAI

Step 8:- Induction wed

Date Start time Completed Induction wed Induction wed Remarks
time done by checked by
26/07/20 9.30pm 1.00pm 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
26/07/20 1.30am 5.30pm VARSHABEN TULSHI BHAI

Step 10:- final packing details:

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

packed packed checked by.
26/07/20 1 KG 100KG 100KG 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 100 198100
2. Mixing
3. Pulveriser
4. Tablet 3
punching
5. Total loss 3

1. Non-recoverable rejection destroyed KG= 3

1. Good Tablet KG= 100
2. Total KG= 103

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