Page 1 of 5

EDITION: 10-15-2015
BATCH MANUFACTURING FORMULA, METHOD and RECORD
CALCIUM CARBONATE ORAL SUSPENSION
1g/5 mL
Form: ORAL SUSPENSION
PROCESS START AND COMPLETION TIMES
START
Time:
Date:

FORMULA AND WEIGHING RECORD

CODE
MATERIAL
Calcium Carbonate
Distilled Water
Sorbitol
Propylene Glycol
Glycerin
Microcrystalline
cellulose
Xanthan Gum
Sodium Saccharin
Mint Flavor

AMOUNT
445.03 g
1, 535.71 mL
271.98 mL
253.00 mL
126.50 mL
13.16 g

ACTUAL AMOUNT

BATCH No.
Batch Size: 2, 300 mL
COMPLETION
Time:
Date:

DISPENSED BY:

CHECKED BY:

7.08 g
2.53 g
0.08 g

Name of Dispenser _______________________ Signature ______ Name of Checker _____________________ Signature ______

MANUFACTURING LOCATION: Liquids Room, Industrial Pharmacy Laboratory

MAJOR EQUIPMENT:
Heidolph Mixer

Batch document issued by: ________________________________________________ Date _____________________________

MASTER DOCUMENT
EFFECTIVE 10-14-2015
Prepared by:

SUPERSEDES:
Approved by:

Production:

Date:

Date:

Date:

Page 2 of 5
EDITION: 10-15-2015
BATCH MANUFACTURING FORMULA, METHOD and RECORD
CALCIUM CARBONATE ORAL SUSPENSION
1g/5 mL
Form: ORAL SUSPENSION
PROCESS START AND COMPLETION TIMES
START
Time:
Date:

BATCH No.
Batch Size: 2, 300 mL
COMPLETION
Time:
Date:

MANUFACTURING INSTRUCTIONS AND RECORDS

Name of Operator ____________________ Signature ________ Name of Checker ______________________Signature ________
DATE
1. Check the equipment to be used.
1.1. Previous equipment use:
Product: Heidolph Mixer
Batch No.: _______________
Date: ___________________
1.2. Last equipment cleandown
Product: Heidolph Mixer
Date: ___________________
2. Obtain clearance from Production
Supervisor and QC that equipment is clean
and ready for use.
Maintenance
QC Clearance
Production Supervisor Clearance
3. Prepare mixture A by dispersing 13.16 g of
Microcrystalline cellulose in water.
4. Prepare mixture B by dispersing 7.08 g of
Xanthan Gum in 115.00 mL Glycerin.
5. Prepare mixture C by dissolving 2.53 g of
Sodium Saccharin in enough Distilled Water.
6. Charge distilled water into the Heidolph
Mixer (Range II, Speed 1)
7. With continuous mixing using Heidolph
Mixer, add mixture A for ten minutes or until
the batch becomes smooth, uniform and free
of lumps
Mixing Start Time

TIME

OPERATOR

CHECKER

Page 3 of 5
EDITION: 10-15-2015
BATCH MANUFACTURING FORMULA, METHOD and RECORD
CALCIUM CARBONATE ORAL SUSPENSION
1g/5 mL
Form: ORAL SUSPENSION
PROCESS START AND COMPLETION TIMES
START
Time:
Date:
Mixing End Time
8. Add the powdered Calcium Carbonate, USP
to the mixture in the Heidolph mixture. Stir
for 5 minutes.
Mixing Start Time
Mixing End Time
9. With continuous stirring, mix in mixture B.
Continue mixing for ten minutes until the
Xanthan Gum is adequately hydrated.
Mixing Start Time
Mixing End Time
10. Add 271.98 mL of Sorbitol.
11. Add 253.00 mL of Propylene glycol.
12. Add mixture C.
13. Add 0.77 mL of mint flavor.
14. Measure the volume of the bulk product.
CALCULATIONS

BATCH No.
Batch Size: 2, 300 mL
COMPLETION
Time:
Date:

Page 4 of 5
EDITION: 10-15-2015
BATCH MANUFACTURING FORMULA, METHOD and RECORD
CALCIUM CARBONATE ORAL SUSPENSION
1g/5 mL
Form: ORAL SUSPENSION
PROCESS START AND COMPLETION TIMES
START
Time:
Date:

BATCH No.
Batch Size: 2, 300 mL
COMPLETION
Time:
Date:

STANDARD ACCEPTABLE BULK YIELD 15. Arrange for Sample of bulk products to be taken by Q.C. sampler.

AUTHORIZED DEVIATIONS FROM STANDARD PROCEDURE

PRIOR AUTHORIZATION: Production ________________________ Date_______ QC ______________________ Date _______

Page 5 of 5
EDITION: 10-15-2015
BATCH MANUFACTURING FORMULA, METHOD and RECORD
CALCIUM CARBONATE ORAL SUSPENSION
1g/5 mL
Form: ORAL SUSPENSION
PROCESS START AND COMPLETION TIMES
START
Time:
Date:

BATCH No.
Batch Size: 2, 300 mL
COMPLETION
Time:
Date:

NON-STANDARD EVENT RECORD (Include explanation of any non-standard yield):

PRODUCTION AND CERTIFICATION: Apart from any authorized deviations, or non-standard events, as recorded above, this batch
has been manufactured in accordance with this BATCH MANUFACTURING FORMULA, METHOD, and RECORD.
Signed: ____________________
Production Supervisor
Date:
____________________

QUALITY CONTROL APPROVAL FOR PACKAGING

This bulk batch of CALCIUM CARBONATE ORAL SUSPENSION Batch No.
RELEASED FOR PACKAGING.
Signed: ____________________
Quality Control
Date:
____________________

has been sampled and tested, and is