BMR Sugar Coated Placebo Tablets

Page 1 of 19
BATCH MANUFACTURING RECORD

PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
Sugar-Coated Placebo
(Sugary V) Tablets
BATCH NO.:
Sugar-Coated Tablets
3,500 tablets
100 tablets/bottle
100-mL wide-mouth amber
flint
PROCESS START AND COMPLETION TIMES

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
Faerie Carleen Lucile L. Almira
(Supervisor)
Black plastic screw-on
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
PERSONNEL INFORMATION
Evaluation
Name
Position (Major/Minor)
Day 1
Day 2
Day 3
Almira, F.
QC
Supervisor
Supervisor
Alvarado, J.
QC
QC
QC
Banzuela, J.
QC
QC
QC
Cabrega, P.
Cahilig, A.
Casimpan, G.
QC
QC
QC
Maintenance
Maintenance
Maintenance
Supervisor
QC
Supervisor
Castro, K.
Maintenance
Maintenance
Maintenance
Debuque, N.
Maintenance
Maintenance
Maintenance
Dela Rosa, K.
Dispensing
Dispensing/
Packaging
Dulawan, J.
Dispensing
Dispensing
Eano, K.
Dispensing
Dispensing
Florentino, D.
Production
Production
Gutlay, K.
Production
Production
Liban, L.
Production
Production
Villafuerte, J.
Production
Production
Dispensing/
Packaging
Dispensing/
QC
Dispensing/
QC
Production/
Packaging
Production/
Packaging
Production/
Packaging
Production/
Packaging
Signature
Punctuality3
Preparedness3
MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

MAJOR EQUIPMENT: Coating pan
BATCH DOCUMENT ISSUED BY:
DATE:
MASTER DOCUMENT EFFECTIVE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:
FAERIE CARLEEN LUCILE L. ALMIRA

GUINEVERE A. CASIMPAN
Date:
Initiative4
Total
Page 2 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
FORMULA AND WEIGHING RECORD

CODE
MATERIAL
Placebo Tablets
AMOUNT
ACTUAL
AMOUNT
DISPENSED BY
CHECKED BY
3,500.00 g
Seal Coating Solution

Kollidon VA 64
79.50 g
Ethanol, 95%
165.00 mL
Subcoating Solution
Sucrose
544.50 g
Acacia
22.30 g
Gelatin
22.30 g
Distilled water
363.00 mL
Grossing Syrup
Sucrose
472.50 g
Subcoating powder
87.20 g
Colorant (10%)
qs
Distilled water
264.00 mL

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
DATE
Page 3 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
Heavy Syrup
Sucrose
95.15 g
Colorant (10%)
qs
Syrup, NF
132.00 mL
Regular Syrup
Sucrose
111.10 g
Colorant (10%)
qs
Distilled water
132.00 mL
Polishing Solution
Sucrose
20.00 g
PEG 8000
30.00 g
Distilled water
50.00 mL
Name of Dispenser:________________________
Name of Checker: _________________________
Signature: ____________
Signature: ____________
MANUFACTURING INSTRUCTION AND RECORD

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 4 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
Name of Operator: _____________________
Name of Checker: __________________________
Signature: _______________
Signature: _______________
PROCEDURE
Check the Plant Log, and enter details of following:
1.1 Previous equipment use:
Product:
Batch No.:
Date:
DATE
TIME
OPERATOR
1.2 Last equipment cleandown

Date:
2 Monitor the following:
Temperature:
Relative Humidity:
3 Obtain clearance from Production Supervisor and
QC that equipment and work area are clean and
ready for use.
Maintenance
QC clearance
Prod. Supervisor clearance
.
4 Screen and dedust tablets.
5 Seal Coating

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
CHECKER
Page 5 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
a.
Apply 50 ml of seal coating solution rapidly

and allow the tablets to roll, with hand
agitation, if necessary, permitting the solution
to spread well over the entire tablet bed.
1st Application
2nd Application
3rd Application
b.
Permit the tablets to roll until they begin to

become tacky, resist separation, and adhere
to each other and to the pan. At this point the
tablets should be dusted with asbestos-free
talc until they just lose their tendency to
adhere to one another. Let the tablets roll for 3
to 5 minutes to prevent agglomeration.
Time Started
Time Ended
Total Time
. jhgjhfjdtutfiygounigiygbiugbiugnuihui
c. At this point the pan should be jogged at 3
minute intervals for 15 minutes.
Time Started:
.

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 6 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
d.
e.
f.
g.
h.
6
1st Interval:
2nd Interval:
3rd Interval:
4th Interval:
Time Ended (5th Interval):
Dry the tablets for one hour with the pan
stopped, the exhaust on, and a supply of cold
air introduced into the bed.
Time Started:
Time Ended:
Total Time:
Check the average tablet thickness and
record them.
Ave. Tablet Thickness:
Apply subsequent sealcoats using the same
technique. Use the same amount of solution
as the process is repeated.
Remove tablets from pan and dedust them.
Wash the pan from any trace of sealcoating

and allow to dry.
Subcoating

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 7 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
a.
Return the tablets to the pan and set the pan

in motion. Turn the exhaust on and do not
apply to the tablet bed.
b. Rapidly wet down the tablets with
approximately 40 mL of warm subcoating
solution.
Volume of Solution:
c. Stir the tablets well by hand to spread the
liquid over the tablets as rapidly and uniformly
as possible.
d. Allow the tablets to roll until they show signs
of being tacky.
Time Started:
Time Ended:
Total Time:
Uniformly dust the tablets with subcoating powder
(previously passed through sieve no. 80 until they
roll freely
e.
Allow the tablets to roll for an additional 15 to

20 minutes to set subcoat.
Time Started:
Time Ended:

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 8 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
f.
g.
h.
Total Time:
Check the average tablet thickness and
record them.
Ave. Tablet Thickness
Apply subsequent subcoats using the same
technique. Use less solution as the process is
repeated (30 ml for the second coat and 20
ml for the succeeding coats). Allow more
drying time between coats.
2nd Application (mL):
Drying Time:
3rd Application (mL):
Drying Time:
4th Application (mL):
Drying Time:
Drying Time:
Drying Time
After subcoating, leave the tablets overnight.

Do not apply air. The tablets may be
periodically jogged.

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 9 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
i.
Remove the tablets from the pan and dedust

them.
j.
Wash the pan from any traces of subcoating

solution and allow to dry.
Grossing
a.
Return the tablets to the pan and set the pan

in motion.
b.
Turn the exhaust on then apply warm air to the

tablet bed.
c.
Apply 30 mL of grossing solution in a thin

steady stream to wet the tablets uniformly.
Volume of Solution:
d.
Stir the tablets well by hand to spread the

as possible.
1st Application:
2nd Application:

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 10 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
3rd Application:
4th Application:
5th Application:
6th application:
7th Application:
8th Application:
e.
Allow the tablets to roll with hot air and

exhaust on until dust just begins to appear in
the air above the tablet bed.
Time Started:
Time Ended:
Total Time:
f.
Check the average tablet thickness and record

them.
g.
Apply subsequent grossing syrup using the

same technique
Coloring material can be added at this stage
with concentration of color continually
increased. The maximum color concentration
should be attained at the last stage of
h.

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 11 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
grossing.
i.
Repeat the process until the tablets are

reasonably smooth and uniformly colored to
the desired tint. Record the amount of FDC
colorant added.
Amt. of Coloring Material:
NOTE: There should be no time lapse
between the Grossing stage and the Heavy
Syrup coating phase.
Heavy Syrup Coating

a
Apply 30 ml of heavy syrup solution in a thin

steady stream to wet the tablets uniformly.
Volume of Heavy Syrup:
b.

liquids over the tablets as rapidly and
uniformly as possible
1st Application:
2nd Application:
3rd Application:

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 12 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
4th Application:
c.
Allow the tablets to roll with hot air and

exhaust until dust begins to appear in the air
above the tablet bed.
Time Started:
Time Ended:
Total Time:
d.

them.
Turn off the hot air completely and reduce the
air exhaust of the pan.
e.
Regular Syrup Coating

a
Set the pan in motion, turn off hot air and

reduce exhaust of the pain.
Apply 15 mL of the regular syrup solution in a

thin stream to wet the tablets uniformly.
Volume of Regular Syrup:

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 13 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\

as possible.
1st Application:
2nd Application:
3rd Application:
4th Application

them.
Repeat the process until desired color is

attained.
10 Finishing
a.
Allow the tablets to roll with exhaust shut off

completely.
b.
Apply three to four coats of 15 ml regular

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 14 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
syrup solution rapidly without permitting the

tablet bed to frost or become dusty.
1st Application:
2nd Application:
3rd Application:
4th Application
c.
After the application of the last coat, shut off

pan while tablets are still damp.
d.
Jog the pan of a turn every minute for the

next 15 minutes.
Time Started:
2nd Interval (time):
3rd Interval (time):
4th Interval (time):

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 15 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
e.

Time ended (15th Interval):
them.
f.
Leave the tablets overnight with no exhaust

and air applies to them with lid closed.
g.
Remove the tablets from the pan and dedust

them.
h.
Wash the pan from any trace of regular syrup

and allow to dry.
11 Polishing
a.
Transfer the tablets to the canvas polishing

pan.

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 16 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
b.
Allow the tablets to roll with the exhaust shut

off completely.
Time Started:
Time Ended:
Total Time:
c.
Apply 15 ml of polishing solution in a thin

stream and allow the tablets to roll.
Vol. of Polishing Soln:
d.
e.
Apply polishing solution immediately and allow

the tablets to roll until they begin to shine.
Time Started:
Time Ended:
Total Time:
Apply a third coat of polishing solution and
allow the tablets to roll until the solution
spread uniformly over the tablets.
Time Started:
Time Ended:

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 17 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
Total Time:
Apply cold air to the tablet bed until the
desired polish is acquired.
Time Started:
Time Ended:
Total Time:
12 Calculate theoretical and actual yield. Account for
losses.
Theoretical Yield:
Actual Yield:
f.
STANDARD ACCEPTABLE BULK YIELD

Arrange for sample of bulk product to be taken by Q.C. sampler.
Accepted by:
AUTHORIZED DEVIATIONS FROM STANDARD PROCEDURE

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 18 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
PRIOR AUTHORIZATION:
PRODUCTION: _________________
QA: __________________________
DATE: ________________________
DATE: ________________________
NON-STANDARD EVENT RECORD: (Include explanation of any non-standard yield)
QUALITY CONTROL APPROVAL FOR PACKAGING

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:
Page 19 of 19
PRODUCT
NAME:
FORM:
BATCH SIZE:
PACKAGING:
BOTTLE:
CAP:
(Sugary V) Tablets
BATCH NO.:
3,500 tablets
100 tablets/bottle
flint

Start
Time:
Date:
Completion
Time:
Date:
APPROVED BY:
(Supervisor)
FMSI-15I01-01
(Supervisor)
\
This bulk batch of ___________________________ Batch No: ______________ has been sampled and tested, and
is released for packaging.
Signed _______________ , Quality Control
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.
Signed _________ , Production Supervisor
Date _____________________________

DATE:
Prepared by:
SUPERSEDES:
Approved by:
Production:
Date:
Date:

Date:

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Page 1 of 19

BATCH MANUFACTURING RECORD

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

FORMULA AND WEIGHING RECORD

Seal Coating Solution

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

Name of Checker: _________________________

MANUFACTURING INSTRUCTION AND RECORD

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

Name of Operator: _____________________

Name of Checker: __________________________

1.2 Last equipment cleandown

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

Apply 50 ml of seal coating solution rapidly

Permit the tablets to roll until they begin to

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

Wash the pan from any trace of sealcoating

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

Return the tablets to the pan and set the pan

Allow the tablets to roll for an additional 15 to

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

After subcoating, leave the tablets overnight.

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

Remove the tablets from the pan and dedust

Wash the pan from any traces of subcoating

Return the tablets to the pan and set the pan

Turn the exhaust on then apply warm air to the

Apply 30 mL of grossing solution in a thin

Stir the tablets well by hand to spread the

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA

PROCESS START AND COMPLETION TIMES

Black plastic screw-on

Allow the tablets to roll with hot air and

Check the average tablet thickness and record

Apply subsequent grossing syrup using the

MANUFACTURING LOCATION: Industrial Pharmacy Laboratory: Solids Room

FAERIE CARLEEN LUCILE L. ALMIRA