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NATURAL WELLNESS INDUSTRIES SDN.

BHD
BATCH MANUFACTURING RECORD

Page 1 of 5 PRODUCT: NW SALICYLIC ACID Batch no:


Pack size: 100 g 2% CREAM
Mfg Date: Batch size: 50 KG Doc no:

Expiry Date: Product Code: Effective date: 09/10/2023

Doc. Issued Date Reg No: MAL17076014XZ Supersedes: NIL


Issued By: Shelf life: 2 YEARS Review Due: 09/10/2025
Prepared by: Verified by: Approved by:

Precaution: Before dispensing complete the checklist in page 3 and follow all the instruction.
Excipient materials shall be dispensed first then, followed by active materials.

Batch
No/
Qty Actual
Lab Dispensed Checked Received
s/n Materials Name Required Quantity
Series By/date By/date By/date
(Kg) Received

1
EMULSIFYING WAX
(Excipient)
4.0

2
LIQUID PARAFFIN
(Excipient)
2.50

3
WHITE SOFT
PARAFFIN 6.50
(Excipient)
4
SODIUM LAURYL
SULFATE 0.45
(Excipient)
5
CETOSTEARYL
ALCOHOL 4.05
(Excipient)
6
CHLOROCRESOL
(Excipient)
0.50

7
WATER
(Excipient)
31.0

8
SALICYLIC ACID
(Active)
1.0

Filename: NW SALICYLIC ACID 2% CREAM BMR 50 KG CONFIDENTIAL AND PROPRIETARY - 1-


NATURAL WELLNESS INDUSTRIES SDN. BHD
BATCH MANUFACTURING RECORD

Page 2 of 5 PRODUCT: NW SALICYLIC ACID Batch no:


Pack size: 100 g 2% CREAM
Mfg Date: Batch size: 50 KG Doc no:

Expiry Date: Product Code: Effective date: 05/10/2023

Doc. Issued Date Reg No: MAL17076014XZ Supersedes: NIL


Issued By: Shelf life: 2 YEARS Review Due: 05/10/2025
Prepared by: Verified by: Approved by:

MANUFACTURING INSTRUCTION –DISPENSING


Previous Product: Batch No: Room ID: Equipment ID:

RH DP Temp Sign Sign/Date Sign/Date


Step Procedures (%) (Pa) (oC) /Date Line QC (if any)
Operator Leader
1 Performed line clearance: (pls  below & sign)

□ No other material in the vicinity


□ Personnel with cleaned gloves, mask &
uniform
□ Equipment cleaned
□ All utensils are cleaned
□ Room is cleared of previous material
□ Room cleaned
2 Remove status labels from room and equipment
and affix them into the BMR.

3 Place materials in Raw Material Buffer Room


and checked
 Name, code number and GRIS number are
correct

4 Ensure bubble spirit level of the digital


weighing scale (small) is in the center of inner
circle
5 Dispense items one by one in the dispensing
page. Counter checked by another person.

6 At the end of dispensing, perform end


clearance
□ Room is been cleared of present batch
material
□ Room is been cleared of present batch
record
7 Send dispensed material to staging area, well
placed on one pallet.

Filename: NW SALICYLIC ACID 2% CREAM 100 G BMR 50 KG CONFIDENTIAL AND PROPRIETARY -2-
NATURAL WELLNESS INDUSTRIES SDN. BHD
BATCH MANUFACTURING RECORD

Page 3 of 5 PRODUCT: NW SALICYLIC ACID Batch no:


Pack size: 100 g 2% CREAM
Mfg Date: Batch size: 50 KG Doc no:

Expiry Date: Product Code: Effective date: 05/10/2023

Doc. Issued Date Reg No: MAL17076014XZ Supersedes: NIL


Issued By: Shelf life: 2 YEARS Review Due: 05/10/2025
Prepared by: Verified by: Approved by:

MANUFACTURING INSTRUCTION - MIXING


Previous Product: Batch No: Room ID: Equipment ID:

RH DP Tem Sign/ Sign/Date Sign/Date


Ste
Procedures (%) (Pa) p DateOp Line QC (if any)
p
(oC) erator Leader
1 Perform line clearance by ensuring ( pls  if
complies, below)

□ Room is cleared of previous batch material


□ Room is cleaned
□ All utensils are cleaned
□ All personnel are with clean gloves and
mask
□ Uniform clean
□ Heater cleaned and assembly correctly
□ Jacketed vessel tank cleaned and assembly
correctly
2 Record of equipment used in: (pls  if
complies, below)
Equipment Used Equipment ID Previous Product/ Batch Remark (if any)
 Heater
 Multi Mixing Tank
 Stainless Steel Stirrer
 Homogenizer
 Automatic Liquid Filling
Machine
 Digital Weighing Scale
(small)
 Digital Weighing Scale
(big)

Comments:

Step Procedures RH DP Tem Sign /Date Sign/Date Sign/Date

Filename: NW SALICYLIC ACID 2% CREAM 100 G BMR 50 KG CONFIDENTIAL AND PROPRIETARY -3-
NATURAL WELLNESS INDUSTRIES SDN. BHD
BATCH MANUFACTURING RECORD

Page 4 of 5 PRODUCT: NW SALICYLIC ACID Batch no:


Pack size: 100 g 2% CREAM
Mfg Date: Batch size: 50 KG Doc no:

Expiry Date: Product Code: Effective date: 05/10/2023

Doc. Issued Date Reg No: MAL17076014XZ Supersedes: NIL


Issued By: Shelf life: 2 YEARS Review Due: 05/10/2025
Prepared by: Verified by: Approved by:

(%) (Pa) p Operator Line QC (if any)


(oC) Leader
3 Bring in the complete dispensed material to
External Liquid Blending Room and check for:
( please  if complies, below)
 Correct name
 Correct batch number (or A.R. No)
 Correct quantity

4
Affix to BMR, the labels from all dispensed
materials as they are being utilized.
5 Mix the following into TANK A (MULTI
MIXING TANK) and heat up to 65 ºC until
dissolve:

EMULSIFYING WAX 4.00 KG 

LIQUID PARAFFIN 2.50 KG 

WHITE SOFT PARAFFIN 6.50 KG 

CETOSTEARYL ALCOHOL 4.05 KG 

SALICYLIC ACID 1.00 KG 

Stir for 30 minutes

Time Start __________ Time Stop __________

6 Then, continually add the following items in


TANK A (MULTI MIXING TANK) and heat
under 65 ºC until dissolve & stir for 30 minutes:

RO WATER 31.00 KG 

SODIUM LAURYL SULFATE 0.45 KG 

CHLOROCRESOL 0.50KG 

Time Start __________ Time Stop ________

Step Procedures RH DP Temp Sign Sign/Date Sign/Date

Filename: NW SALICYLIC ACID 2% CREAM 100 G BMR 50 KG CONFIDENTIAL AND PROPRIETARY -4-
NATURAL WELLNESS INDUSTRIES SDN. BHD
BATCH MANUFACTURING RECORD

Page 5 of 5 PRODUCT: NW SALICYLIC ACID Batch no:


Pack size: 100 g 2% CREAM
Mfg Date: Batch size: 50 KG Doc no:

Expiry Date: Product Code: Effective date: 05/10/2023

Doc. Issued Date Reg No: MAL17076014XZ Supersedes: NIL


Issued By: Shelf life: 2 YEARS Review Due: 05/10/2025
Prepared by: Verified by: Approved by:

(%) (Pa) (oC) /Date Line Leader QC (if any)


Operator
7 Submit sample (100 g) to Q.C Laboratory for pH
checking and assay testing

pH Specification : 3.0 – 6.0

Actual pH: _________

Viscosity : 10 000 – 60 000 cP

Actual Viscosity: _________

8 Transfer the cream into the filling machines.


Maintain temperature of Multi Mixing Tank at 40-
42 °C if possible, to assist transferring process.

9 Check the External Liquid Filling room is ready


for transfer of Liquid with Line Clearance
completed.

10 Transfer the bulk to the holding tank on the ground


floor by filtering through filter press.

11 Perform end clearance


Room is been cleared of present batch material
Room is been cleared of present batch record

12 Submit Batch Manufacturing Record to Production


Executive/Manager.
PRODUCTION SECTION HEAD:

Filename: NW SALICYLIC ACID 2% CREAM 100 G BMR 50 KG CONFIDENTIAL AND PROPRIETARY -5-

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