01 BMR Placebo Tablets

BATCH MANUFACTURING, FORMULA, METHOD AND RECORD
ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

(EFF-CEE)
Form: EFFERVESCENT TABLET Batch Size: 600 TABLETS
PROCESS START AND COMPLETION TIMES
START: TIME: COMPLETION: TIME:
DATE: DATE:

ASSIGNMENT OF ROLES
NAME ROLE INITIALS SIGNATURE
BALUTOC, Iris Patrisha Supervisor
GONZAGA, Mary France Production Head
SORIA, Marie Claire Production
DELA ROSA, Paula Dispensing
PO, Sharmaine Kae Quality Assurance/ Quality Control
VILLAFUERTE, Jillian Quality Assurance/ Quality Control
LEGASPI, Donato Packaging and Labelling
ARGONZA, Femina Maintenance
FORMULA AND WEIGHING RECORD

ACTUAL
CODE MATERIAL AMOUNT DISPENSED BY CHECKED BY
AMOUNT
Ascorbic Acid 300 g
F19 PVP 72 g
N/A 95% Ethanol 175 mL
J5 Sucrose 36 g
Aspartame 16.20 g
E12 Citric Acid Monohydrate 180 g
J8 Tartaric Acid 90 g
Sodium Bicarbonate 360 g
PEG 6000 28.80 g
C25 Orange flavour (powder) 117 g
Name of Dispenser: _____________________________ Name of Checker: ______________________________

Signature: _______________________________________ Signature: ______________________________________
Batch Document Issued by: BALUTOC, Iris Patrisha Abigail C. Date: ______________________
MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

Prepared by: Approved by: Production:
BALUTOC, Iris Patrisha Abigail C. PO, Sharmaine Kae D. GONAZAGA, Mary France R.
Date: Date: Date:

Page 1 of 10


(EFF-CEE)
DATE: DATE:

MANUFACTURING LOCATION: Solids Room, Industrial Pharmacy Laboratory, College of Pharmacy,
University of the Philippines, Manila
MAJOR EQUIPMENT: Sigma Blade Mixer – Model: Stokes F

Tablet Press – Model: Stokes F
Oscillating Granulator – Model: Stokes F, Single Arm Mixer
Drying Oven – Model:
MANUFACTURING INSTRUCTIONS AND RECORD
Name of Operator: _____________________________ Name of Checker: ______________________________

Signature: ______________________________________ Signature: ______________________________________
PROCEDURE DATE TIME PERFORMED BY CHECKED BY

1. Check the Plant Log, and enter Start:
details of following: End:
1.1 Previous equipment use:
Product:
Batch No.
Date
1.2 Last equipment cleandown
Date
Start:
2. Obtain clearance from Production
End:
Supervisor and QC that equipment
is clean and ready for use
Maintenance
QC clearance
Production
Supervisor clearance


Date: Date: Date:

Page 2 of 10


(EFF-CEE)
DATE: DATE:

3. Prepare granulating solution by Start:
adding PVP to ethanol. End:
4. Screen citric acid and tartaric acid Start:
End:
through a no. 40 Sieve. This is
granulation A.
5. Screen sodium bicarbonate through Start:
a no. 40 Sieve. This is granulation B. End:
6. Screen ascorbic acid, PEG 6000,
sucrose, aspartame, powdered Start:
orange flavour separately through a End:
no. 40 sieve.
7. Transfer granulation A to the sigma Start:
blade mixer and add enough End:
granulating solution; mix until the
endpoint is reached.
Start:
st
1 addition End:
Start:
nd
2 addition End:
Start:
rd
3 addition End:
Start:
th
4 addition End:
Start:
th
5 addition End:

Date: Date: Date:

Page 3 of 10


(EFF-CEE)
DATE: DATE:

Start:
8. Pass the moistened mass formed
End:
into balls through a no. 4 mesh
screen. (Granules A)
9. Spread the moist Granules A on trays Start:

and place in the drying oven set at End:
60°C for 15-30 minutes.
Start:
10. Determine LOD of dried granules A. End:
Start:
11. Re-dry granules A if moisture End:
content is more than 5%.
Start:
12. Pass the dried granules A through End:
the oscillating granulator with a no.
20 screen attached.
Start:
13. Regranulate the portion of granules End:
A that passes through sieve no. 40.
14. Combine the good granules and Start:

fines of A (10% of the weight of the End:
good granules).
Weight of Good A _______________
Weight of Fine A _______________


Date: Date: Date:

Page 4 of 10


(EFF-CEE)
DATE: DATE:

15. Transfer granulation B to the sigma Start:
blade mixer and add enough End:
granulating solution; mix until the
endpoint is reached.
Start:
st
1 addition End:
Start:
nd
2 addition End:
Start:
rd
3 addition End:
Start:
th
4 addition End:
Start:
th
5 addition End:
16. Pass the moistened mass formed Start:

into balls through a no. 4 mesh End:
screen. (Granules B)
17. Spread the moist Granules B on Start:
trays and place in the drying oven End:
set at 60°C for 15-30 minutes.
Start:
18. Determine LOD of dried granules B. End:
Start:
19. Re-dry granules B if moisture
End:
content is more than 5%.


Date: Date: Date:

Page 5 of 10


(EFF-CEE)
DATE: DATE:

20. Pass the dried granules B through Start:
the oscillating granulator with a no. End:
20 screen attached.
Start:
21. Regranulate the portion of granules End:
B that passes through sieve no. 40.
22. Combine the good granules and Start:

fines of B (10% of the weight of the End:
good granules).
Weight of Good B _______________
Weight of Fine B _______________
23. Transfer granules A, granules B, Start:
sucrose, aspartame, and the End:
orange powder flavor to a clear,
polyethylene bag.
Start:
24. Transfer the screened ascorbic acid
End:
into the polyethylene bag.
Start:
25. Tumble-mix the powders for 10
End:
minutes.
Start:
26. Add the screened PEG 6000 into the
End:
polyethylene bag.
Start:
27. Tumble-mix the powders for 3
End:
minutes.
28. After mixing, obtain the weight of Start:
the combined powders and End:
granules. Label the bag as, “For
tableting”.

Date: Date: Date:

Page 6 of 10


(EFF-CEE)
DATE: DATE:

29. Perform In-Process Quality Control Start:
on the combined granules. End:
Start:
a. Bulk Density
End:
Start:
Tapped Density
End:
Start:
b. Angle of Repose End:
Start:
c. Compressibility Index End:
Start:
Hausner Ratio End:
Start:
d. Moisture Content End:
Start:
e. Particle Size Distribution End:
Start:
30. Compress into tablets using ¾’ End:
punches.

Date: Date: Date:

Page 7 of 10


(EFF-CEE)
DATE: DATE:

Start:
31. Compress into tablets using 7/16’ End:
flat, concave punches.
32. Perform FPQC every ten minutes Start:

and record as X on the control End:
chart. Record all retest as R.
Start:
a. Physical appearance and taste
End:
b. pH Start:
End:
c. Hardness Start:
End:
d. Thickness Start:
End:
e. Weight Variation Start:
End:
f. Friability Start:
End:
g. Effervescence Start:
End:
h. Assay Start:
End:
Start:
33. Calculate theoretical and actual
End:
yield. Account for losses.
Theoretical Yield _________________
Actual Yield ______________________
Losses ___________________________

Date: Date: Date:

Page 8 of 10


(EFF-CEE)
DATE: DATE:

STANDARD ACCEPTABLE BULK YIELD: 570 – 630 TABLETS
Arrange for sample of bulk product to be taken by QC sampler
AUTHORIZED DEVIATIONS FROM THE STANDARD PROCEDURE:
PRIOR AUTHORIZATION:
Production: _______________ QA: ________________________
Date: ______________________ Date: ______________________
NON-STANDARD EVENT RECORD (Include any explanation of any non-standard yield)

Date: Date: Date:

Page 9 of 10


(EFF-CEE)
DATE: DATE:

PRODUCTION 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.
Production Supervisor: ______________________

Signature: ___________________________________
Date: ________________________________________
QUALITY CONTROL APPROVAL FOR PACKAGING
This bulk batch of PLACEBO TABLETS Batch Scale-Up

Has been sampled and tested, and is RELEASED FOR PACKAGING.
Quality Control: _____________________________

Signature: ___________________________________
Date: ________________________________________
-NOTHING FOLLOWS-

Date: Date: Date:

Page 10 of 10

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BATCH MANUFACTURING, FORMULA, METHOD AND RECORD

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

FORMULA AND WEIGHING RECORD

Name of Dispenser: _____________________________ Name of Checker: ______________________________

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

MAJOR EQUIPMENT: Sigma Blade Mixer – Model: Stokes F

MANUFACTURING INSTRUCTIONS AND RECORD

Name of Operator: _____________________________ Name of Checker: ______________________________

PROCEDURE DATE TIME PERFORMED BY CHECKED BY

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

9. Spread the moist Granules A on trays Start:

14. Combine the good granules and Start:

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

16. Pass the moistened mass formed Start:

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

22. Combine the good granules and Start:

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

32. Perform FPQC every ten minutes Start:

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

STANDARD ACCEPTABLE BULK YIELD: 570 – 630 TABLETS

Arrange for sample of bulk product to be taken by QC sampler

AUTHORIZED DEVIATIONS FROM THE STANDARD PROCEDURE:

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

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

ASCORBIC ACID EFFERVESCENT TABLETS Batch: Scale-Up

PRODUCTION CERTIFICATION: Apart from any authorized deviations, or non-standard events, as

Production Supervisor: ______________________

QUALITY CONTROL APPROVAL FOR PACKAGING

This bulk batch of PLACEBO TABLETS Batch Scale-Up

Quality Control: _____________________________

MASTER DOCUMENT EFFECTIVE: 28 Aug 2015 SUPERSEDES: N/A

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Name of Dispenser: _ Name of Checker: __

Name of Operator: _ Name of Checker: __