BREGMA SCIENCE LLP BANGALORE Page 1 of 6

BATCH MANUFACTURING RECORD

Document No Effective Date Supersedes Doc. No & Date Prepared By: QA
Executive (Sign/Date)
BMR/IN/MC/00 & 10-MAY-
BMR/IN/MC/01
2021
Product: Moisturizing cream Location: Bregma Science, Bangalore
Market: Domestic Mfg. Lic. No.:
Batch No.: Standard Batch Size: 100 Kg

PRODUCT NAME: Moisturizing cream

SEMI FINISHED PRODUCT CODE: 3000464

REFERENCE MFR No.: IN/MC/01

BATCH NUMBER: MC -001

ACTUAL BATCH SIZE: 100 Kg

MANUFACTURING DATE: 10-Jun-2021

EXPIRY DATE: 10-May-2023

SHELF LIFE: 24 Months

BATCH COMMENCED ON:

BATCH COMPLETED ON:

TOTAL QUANTITY FILLED: ___________Kg

MANUFACTURING YIELD: ___________%

BATCH YIELD: ___________%

QUANTITY RELEASED FOR SALES: ___________

ANY BREAK DOWN / DEVIATION / INCIDENT:

This Batch Manufacturing record is Checked & Authorized by the following:

Checked by: Manager-Production Authorized by: Manager-QA
Name
Sign & Date

This Batch Manufacturing Record Contains Page No.1 to 8 Issued by QA

(Sign & date):

Executed Batch record Reviewed By: Executed Batch record Reviewed By:
(Manager - Production) (Manager-QA)
Date: Date:

Property Information: This document and the contents hereof are considered proprietary and confidential information of Bregma Science LLP. Disclosure to unauthorized
individuals or dissemination, publication or copying is prohibited without the prior written consent.
 BREGMA SCIENCE LLP BANGALORE Page 2 of 6
BATCH MANUFACTURING RECORD
Document No Effective Date Supersedes Doc. No & Date Prepared By: QA
Executive (Sign/Date)
BMR/IN/MC/00 & 10-MAY-
BMR/IN/MC/01
2021
Product: Moisturizing cream Location: Bregma Science, Bangalore
Market: Domestic Mfg. Lic. No.:
Batch No.: Standard Batch Size: 100 Kg

1.0 Critical control points:

 The manufacturing vessel, working table and the accessories used in the process should be thoroughly
cleaned and then used for batch manufacturing and filling.
 Do not switch-on the homogeniser once cooling starts.
 Do not apply vacuum after adding fragrance.
 The product should be filled no later than 24 hours after manufacturing the bulk
2.0 DISPENSING:

2.1 Clean the area & equipments as per SOP & get line clearance from QA.

2.2 LINE CLEARANCE FOR DISPENSING: Date:

Observation Checked Verified

Parameters
(Yes/No) by by (QA) Cubical No.:
Cleanliness of the Dispensing area as per ____________
SOP……………………………
Previous Product:
Cleanliness of SS Containers, Scoops & ___________________
accessories
Labels / records of previous batch removed Batch No.:
Logbooks updated _____________

Weighing Balance code: ………………….. Line clearance given at:

Weighing Balances are calibrated as per _____
SOP…………………………………
Cleaned status Label updated Dispensing started at:
______

Dispensing completed at:

________

2.3 Attach CLEANED status label of the equipment to the Batch Record.
2.4 Get the raw material indent checked & authorized.
2.5 Dispense the materials in clean polythene covers / drums as per the SOP.
2.6 Label the dispensed materials & complete the indent.
2.7 Send the completed indent along with the dispensed materials to production.
Line Clearance Initiated by Stores Supervisor (Sign/date) __________ / time: __________

Line Clearance SOP No.: __________________, by QA (Sign/date) __________/ time: __________

Property Information: This document and the contents hereof are considered proprietary and confidential information of Bregma Science LLP. Disclosure to unauthorized
individuals or dissemination, publication or copying is prohibited without the prior written consent.
 BREGMA SCIENCE LLP BANGALORE Page 3 of 6
BATCH MANUFACTURING RECORD
Document No Effective Date Supersedes Doc. No & Date Prepared By: QA
Executive (Sign/Date)
BMR/IN/MC/00 & 10-MAY-
BMR/IN/MC/01
2021
Product: Moisturizing cream Location: Bregma Science, Bangalore
Market: Domestic Mfg. Lic. No.:
Batch No.: Standard Batch Size: 100 Kg

2.8 RAW MATERIAL INDENT

2.0 BILL OF MATERIALS

U Qty.
S. % ADDN
Material Description INCI Name O Per Batch
No. w/w
M (in Kgs)
1 Water Aqua Kg 86.00 86.00
2 Glycerin Glycerin Kg 5.00 2.00
3 Coconut oil Coconut oil Kg 4.00 2.00
4 Cetostearyl alcohol Cetearyl Alcohol Kg 1.00 1.00
5 GMS-SE Glyceryl Monostearate Kg 1.00 1.00
6 Cetyl alcohol Cetyl Alcohol Kg 0.50 0.50
7 Phenoxyethanol Phenoxyethanol Kg 0.50 0.50
8 Sodium benzoate Sodium Benzoate Kg 0.50 0.50
9 Vitamin E acetate Tocopheryl Acetate Kg 0.50 0.50
10 Withania Somnifera Kg
Ashwagandha powder (Ashwagandha)Powder 0.50 0.50
11 Fragrance Fragrance Kg 0.50 0.10
Total 100 100

NOTE: Production & QA has to Check & Verify Raw Materials indent detail against SAP Approved Process order.

Checked by Production: - Sign: ________ & date: ________, Verified by QA: - Sign: ________ & date: ________

3.0: LINE CLEARANCE FOR MANUFACTURING:

3.1 Wear nose mask and hand gloves during manufacturing.
3.2 Clean the area & equipments as per SOP & get the line clearance from QA.
3.3 Cross verify the weight of the dispensed raw Materials against process order.

Property Information: This document and the contents hereof are considered proprietary and confidential information of Bregma Science LLP. Disclosure to unauthorized
individuals or dissemination, publication or copying is prohibited without the prior written consent.
 BREGMA SCIENCE LLP BANGALORE Page 4 of 6
BATCH MANUFACTURING RECORD
Document No Effective Date Supersedes Doc. No & Date Prepared By: QA
Executive (Sign/Date)
BMR/IN/MC/00 & 10-MAY-
BMR/IN/MC/01
2021
Product: Moisturizing cream Location: Bregma Science, Bangalore
Market: Domestic Mfg. Lic. No.:
Batch No.: Standard Batch Size: 100 Kg

CKD BY PREVIOUS B.No.

PARAMETERS OBSERVATIONS
(Prod) (QA) PRODUCT
AREA CHECKS:
Cleanliness of the area as per SOP
EQUIPMENT CHECKS: BALANCE: Equipment Number: MSA/PROD/73
Cleanliness of weighing balance
Calibration of weighing balance
EQUIPMENT CHECKS: Cleanliness of SS pot as per SOP:
Equipment Number: Kettle No. 1:
Kettle No. 2:
Cleanliness of SS pot inner surface of the tank
Cleanliness of the valves
Proper closure of bottom outlet valve
Thorough dryness of the Inner surface of the
tank
Thorough dryness of the bottom outlet Valves
Cleanliness of the outer surface
Updation of logbook
Updation of status labels
Cleanliness of the outer surface
OTHER ACCESSORIES
Cleanliness of SS vessels used
Cleanliness of Spatula
Cleanliness of other accessories used

Attach CLEANED status label of the equipment to the Batch Record.

Line Clearance Initiated by Production (Sign/date) __________ / time: __________

Line Clearance SOP No.: __________________, by QA (Sign/date) __________/ time: __________

4.0: MANUFACTURING:
4.1 Countercheck the weight of dispensed quantities.

Date Step Materials Quantity Time Observation Done Checked.

Property Information: This document and the contents hereof are considered proprietary and confidential information of Bregma Science LLP. Disclosure to unauthorized
individuals or dissemination, publication or copying is prohibited without the prior written consent.
 BREGMA SCIENCE LLP BANGALORE Page 5 of 6
BATCH MANUFACTURING RECORD
Document No Effective Date Supersedes Doc. No & Date Prepared By: QA
Executive (Sign/Date)
BMR/IN/MC/00 & 10-MAY-
BMR/IN/MC/01
2021
Product: Moisturizing cream Location: Bregma Science, Bangalore
Market: Domestic Mfg. Lic. No.:
Batch No.: Standard Batch Size: 100 Kg

No. (Kg) From To by by

Temp.:
To the main mixing vessel, thru ---
100# muslin cloth charge
01
Water 84
Add ---
Glycerin 5
Mix well for 5-10 min. ---
Start heating the main mixing --- Temp:
vessel & bring temperature to
75 – 80°C.
In a side melting vessel, add one
by one
4
Coconut oil
1
Cetostearyl alcohol
0.5
Cetyl alcohol
1
GMS- SE

Heat the mixture with constant

stirring to avoid charring at the
02 bottom.
Once the temperature reaches
75-80°C, switch-on the
homogenizer in the main mixer
& add phase C to main mixer
slowly.
Continue homogenization for
15-20 mins, maintain the
temperature of the main mixer
between 70-75°C.
Once the homogenization is
complete, start cooling the
mixture in the main vessel.
Dissolve in completely.
03
Sodium benzoate 0.5

Property Information: This document and the contents hereof are considered proprietary and confidential information of Bregma Science LLP. Disclosure to unauthorized
individuals or dissemination, publication or copying is prohibited without the prior written consent.
 BREGMA SCIENCE LLP BANGALORE Page 6 of 6
BATCH MANUFACTURING RECORD
Document No Effective Date Supersedes Doc. No & Date Prepared By: QA
Executive (Sign/Date)
BMR/IN/MC/00 & 10-MAY-
BMR/IN/MC/01
2021
Product: Moisturizing cream Location: Bregma Science, Bangalore
Market: Domestic Mfg. Lic. No.:
Batch No.: Standard Batch Size: 100 Kg

Water 2
Add this mixture to main mixing
vessel at 40-42°C
Slowly add to the main mixing
vessel & mix well.
04 Ashwagandha powder (0.5%) 0.5
Ensure no lumps are formed.
In a suitable vessel, mix and Mix
well to form a homogenous
mixture.
Phenoxyethanol 0.5

05 Fragrance 0.5
Vitamin E acetate 0.5
Add this mixture to main mixing
vessel at 40°C & mix well for 15
min.
Filter the final product through
06 100# nylon cloth & Send sample
to QC for analysis.

5.0 UNLOADING DETAILS:

5.1 Unload the bulk from main tank at 40°C to clean & dry SS Vessel.

Unloading Done By:

6.0 BATCH SUMMARY

Loss BMR reviewed by
Section Head-Production Quality Assurance
Date Date

Signature (Section Head): Signature (QA):

Date: Date:

Property Information: This document and the contents hereof are considered proprietary and confidential information of Bregma Science LLP. Disclosure to unauthorized
individuals or dissemination, publication or copying is prohibited without the prior written consent.