Professional Documents
Culture Documents
Sugar-Coated Placebo
(Sugary V) Tablets
BATCH NO.:
Sugar-Coated Tablets
3,500 tablets
100 tablets/bottle
100-mL wide-mouth amber
flint
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
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Initiative4
Total
Page 2 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
MATERIAL
Placebo Tablets
AMOUNT
ACTUAL
AMOUNT
DISPENSED BY
CHECKED BY
3,500.00 g
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
SUPERSEDES:
Approved by:
Production:
Date:
Date:
DATE
Page 3 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
FMSI-15I01-01
Guinevere A. Casimpan
(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:________________________
Signature: ____________
Signature: ____________
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 4 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
Signature: _______________
Signature: _______________
PROCEDURE
Check the Plant Log, and enter details of following:
1.1 Previous equipment use:
Product:
Batch No.:
Date:
DATE
TIME
OPERATOR
SUPERSEDES:
Approved by:
Production:
Date:
Date:
CHECKER
Page 5 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
a.
b.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 6 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
FMSI-15I01-01
Guinevere A. Casimpan
(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.
Subcoating
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 7 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
a.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 8 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
FMSI-15I01-01
Guinevere A. Casimpan
(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:
5th Application (mL):
Drying Time:
6th Application (mL):
Drying Time
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 9 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
i.
j.
Grossing
a.
b.
c.
d.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 10 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
3rd Application:
4th Application:
5th Application:
6th application:
7th Application:
8th Application:
e.
f.
g.
h.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 11 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
grossing.
i.
b.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 12 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
4th Application:
c.
d.
e.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 13 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
10 Finishing
a.
b.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 14 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
d.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 15 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
e.
f.
g.
h.
11 Polishing
a.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 16 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
b.
c.
d.
e.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 17 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
FMSI-15I01-01
Guinevere A. Casimpan
(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.
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 18 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
FMSI-15I01-01
Guinevere A. Casimpan
(Supervisor)
\
PRIOR AUTHORIZATION:
PRODUCTION: _________________
QA: __________________________
DATE: ________________________
DATE: ________________________
SUPERSEDES:
Approved by:
Production:
Date:
Date:
Page 19 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
FMSI-15I01-01
Guinevere A. Casimpan
(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 _____________________________
SUPERSEDES:
Approved by:
Production:
Date:
Date: