NATURAL WELLNESS INDUSTRIES SDN.

BHD
BATCH MANUFACTURING RECORD
Page 1 of 5 PRODUCT: CALAMINE CREAM Batch no:
Pack size: 30g/ 60g/ 120g
Mfg Date : Batch size: 200 KG Doc no:
Expiry Date : Product Code: Effective date:
Doc. Issued Date : Reg No: Supercedes: NIL
Issued By: Shelf life: 2 YEARS Review Due:
Prepared by: Verified by: Approved by:
QA Executive Production Executive QC HOD

Precaution: Before dispensing complete the checklist in page 3 and follow all the instruction

Percenta
Actual
ge
Qty Quantit Checke Receive
S/ Batch No/ weight Dispense
Materials Name Unit Require y d d
n Lab Series for d By/date
d Receive By/date By/date
weight
d
(%w/w)
1 Calamine Kg 10 5%
2 Zinc Oxide Kg 10 5%
3 Glycerin Kg 20 10%
4 Purified Water Kg 130.60 65.3%
5 Cetyl Alcohol Kg 5 2.5%
6 Glyceril Stearate (Peg
Kg 20 10%
100 Stearate)
7 Methyl Paraben Kg 0.36 0.18%
8 Propyl Paraben Kg 0.04 0.02%
9 Cellulose
Kg 4 2%
Microcrystalline

Filename: CALAMINE CREAM BMR 200Kg CONFIDENTIAL AND PROPRIETARY -1-

 NATURAL WELLNESS INDUSTRIES SDN. BHD
BATCH MANUFACTURING RECORD
Page 2 of 5 PRODUCT: CALAMINE CREAM Batch no:
Pack size: 30g/ 60g/ 120g
Mfg Date : Batch size: 200 Kg Doc no:
Expiry Date : Product Code: Effective date:
Doc. Issued Date : Reg No: Supercedes: NIL
Issued By: Shelf life: 2 YEARS Review Due:
Prepared by: Verified by: Approved by:
QA Executive Production Executive QC HOD

MANUFACTURING INSTRUCTION –DISPENSING

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

RH Temp Sign /Date Sign/Date Sign/

Step Procedures
(%) (oC) Operator Line Leader Date QC
1 Performed line clearance: (please  below & sign)
 No other material in the vicinity  Personnel with gloves, mask & uniform clean
 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 Dispense items one by one in the dispensing page.
Counter checked by another person.
5 At the end of dispensing, perform end clearance
 Room is been cleared of present batch material
 Room is been cleared of present batch record
6 Send dispensed material to staging area, well placed on
one pallet.

Filename: CALAMINE CREAM BMR 200Kg CONFIDENTIAL AND PROPRIETARY -2-

 NATURAL WELLNESS INDUSTRIES SDN. BHD
BATCH MANUFACTURING RECORD
Page 3 of 5 PRODUCT: CALAMINE CREAM Batch no:
Pack size: 30g / 60g/ 120g
Mfg Date : Batch size: 200 Kg Doc no:
Expiry Date : Product Code: Effective date:
Doc. Issued Date : Reg No: Supercedes: NIL
Issued By: Shelf life: 2 YEARS Review Due:
Prepared by: Verified by: Approved by:
QA Executive Production Executive QC HOD

MANUFACTURING INSTRUCTION - MIXING

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

RH Temp Sign /Date Sign/Date Sign/

Step Procedures
(%) (oC) Operator Line Leader Date QC
1 Perform line clearance by ensuring (please  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  Jacketed vessel cleaned and assembly correctly
 Stainless steel stirrer cleaned and assembly correctly  Homogenizer cleaned and assembly correctly
2 Record of equipment used in: (please  if complies,
below)
Activity in Previous
Equipment Used Equipment ID Room Remarks
progress Product/ Batch
Heater
Jacketed Vessel Tank
100 L
Jacketed Vessel Tank
200 L
Stainless Steel Stirrer
Homogenizer
Automatic Liquid
Filling Machine
Shrink Tunnel
Machine
Digital Weighing
Scale

Comment:

Filename: CALAMINE CREAM BMR 200Kg CONFIDENTIAL AND PROPRIETARY -3-

 NATURAL WELLNESS INDUSTRIES SDN. BHD
BATCH MANUFACTURING RECORD
Page 4 of 5 PRODUCT: CALAMINE CREAM Batch no:
Pack size: 30g / 60g/ 120g
Mfg Date : Batch size: 200 Kg Doc no:
Expiry Date : Product Code: Effective date:
Doc. Issued Date : Reg No: Supercedes: NIL
Issued By: Shelf life: 2 YEARS Review Due:
Prepared by: Verified by: Approved by:
QA Executive Production Executive QC HOD

RH Temp Sign /Date Sign/Date Sign/

Step Procedures
(%) (oC) Operator Line Leader Date QC
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 Transfer the following into TANK A (JACKETED
TANK)

►PURIFIED WATER 130.60 KG 

o
Heat up the water until 70 C.
0

6 Transfer the following into TANK B

► GLYCERIN 20.00 KG 
► CETYL ALCOHOL 5.00 KG 
► GLYCERYL STEARATE 20.00 KG 
► CELLULOSE MICROCRYSTALLINE
4.00 KG 

Stir for 30 minutes.

Time Start _____________ Time Stop _____________

7 Reduce the temperature to 45oC, and add the following

into TANK B.

► CALAMINE 10.00 KG 
► ZINC OXIDE 10.00 KG 

► METHYL PARABEN 0.36 KG 

► PROPYL PARABEN 0.04 KG 

Stir for 40 minutes.

Allow to cool.

Filename: CALAMINE CREAM BMR 200Kg CONFIDENTIAL AND PROPRIETARY -4-

 NATURAL WELLNESS INDUSTRIES SDN. BHD
BATCH MANUFACTURING RECORD
Page 5 of 5 PRODUCT: CALAMINE CREAM Batch no:
Pack size: 30g / 60g/ 120g
Mfg Date : Batch size: 200 Kg Doc no:
Expiry Date : Product Code: Effective date:
Doc. Issued Date : Reg No: Supercedes: NIL
Issued By: Shelf life: 2 YEARS Review Due:
Prepared by: Verified by: Approved by:
QA Executive Production Executive QC HOD

8 Collect about 0.5 L of the bulk liquid from the

outlet valve in a stainless steel container and
transfer back to the main bulk. Stir for 30
minutes.
Time Start __________ Time Stop __________

9 Remove from the outlet valve about 0.2 L of the

bulk liquid and keep it aside in a stainless steel
container. Measure the volume of the liquid.

Volume of bulk liquid _________ L

10
Rinse the silicone transfer hose with the 0.2 L of
the bulk liquid from process 9. Reject the liquid at
the end of the procedure.
11 Submit sample (100 mL) to Q.C Laboratory.

12 Check the External Liquid Filling room is ready

for transfer of Liquid with Line Clearance
completed.
13 Transfer the bulk to the holding tank on the
ground floor by filtering through filter press.
14 Perform end clearance
Room is been cleared of present batch material
Room is been cleared of present batch record

15 Submit Batch Manufacturing Record to

Production Executive/Manager.
PRODUCTION SECTION HEAD:

Filename: CALAMINE CREAM BMR 200Kg CONFIDENTIAL AND PROPRIETARY -5-