Batch Manufacturing Formula, Method and Record: Punctua-Lity (30%) Prepared - Ness (35%) Initiative (35%) Total (100%)

Page 1 of 6
BATCH MANUFACTURING FORMULA,

METHOD AND RECORD
Product Name: PLEXCIBO Batch No.: APTCPLX001
Form: Tablet Batch Size: 3,000 tablets

Packaging: 100 tablets/bottle
PROCESS START AND COMPLETION TIMES

Start Time: Completion Time:
Date: Date:
SIGNATURE SPECIMEN AND EVALUATION
Evaluation
Name Position Signature Punctua- Prepared- Initiative Total
lity ness (35%) (100%)
(30%) (35%)
Olarve, Kezia Jahzeel V. Supervisor
Eleda, Nathalie Vivielle B. Quality Assurance
Nanali, Earl Vincent C. Quality Control Head
Aguilar, Eionn Philip O. Quality Control
Amistad, Anne Roselle Mae A. Production Head
Rimorin, K-Be B. Production
Vinoya, Paulyne Grace L. Dispensing Head
Bueno, Samantha Ayessa P. Packaging Head
Yarte, Jeyhanz Anthony C. Maintenance
Bagunu, Alain Mariel G. Maintenance
MASTER DOCUMENT EFFECTIVE SUPERSEDES:
Prepared by: Approved by: Production:
Kezia Jahzeel V. Olarve Nathalie Vivielle B. Eleda Anne Roselle Mae A. Amistad
Supervisor Quality Assurance Production Head
Date: Date: Date:

Page 2 of 6
METHOD AND RECORD

FORMULA AND WEIGHING RECORD
CODE MATERIAL AMOUNT LOT No. DISPENSED CHECKED

BY: BY:
THEORETICAL ACTUAL
Lactose 3,641.00 g
Starch 181.50 g
Starch for Starch Paste 82.50 g
Magnesium Stearate 38.50 g
Distilled water for Starch 825.00 mL

Paste
Name of Dispenser _______________Signature ____________ Name of Checker _______________ Signature ____________
MANUFACTURING LOCATION: Manufacturing Laboratory, 3rd Floor, College of Pharmacy Building, De La Salle Medical and
Health Sciences Institute, City of Dasmariñas, Cavite
MAJOR EQUIPMENT: Mixer

Oven
Granulator
Table-top concave punches tablet press
Batch document issued by: ______________________________________________ Date: _______________________________
Date: Date: Date:

Page 3 of 6

METHOD AND RECORD

MANUFACTURING INSTRUCTIONS AND RECORD
Name of Operator _______________Signature ____________ Name of Checker _______________ Signature ____________
DATE TIME STARTED TIME ENDED OPERATOR CHECKER
1. Check the Plant Log, and enter the

details of the following:
1.1. Previous equipment use:
Product:
Batch No.:
Date:
1.2. Last equipment clean down
Date:
2. Obtain clearance from the

Production Supervisor and QC that
equipment is clean and ready for
use.
Maintenance
QC clearance
Prod. Supervisor clearance
3. Check the initial temperature.

Liquids Room: _____
Quality Control Room: _____
Packaging Room: _____
4. Check initial humidity.

Liquids Room: _____
Quality Control Room: _____
Packaging Room: _____
Date: Date: Date: Page 4 of 6

METHOD AND RECORD

MANUFACTURING INSTRUCTIONS AND RECORD (cont.)
5. Procedure
5.1. Screen through no. 40 sieve:
Lactose
Starch
5.2. Preparation of Starch Paste:
Boil about 600 mL of water.
Dispense the starch in the
remaining water. Add the
starch solution into the boiled
water and stir until a
translucent paste forms.
5.3. Weigh and mix the lactose
and starch using the mixer
for 10 minutes at speed 1.
5.4. Incorporate the required
amount of starch paste and
mix thoroughly. Check if the
mixing has reached its end-
point.
5.5. Pass the moistened mass
formed into the balls through
a mesh.
5.6. Spread the moist granules on
trays and place in the drying
oven set at 140ºF.
5.7. Check for moisture content.
5.8. Pass the dried granules
through the granulator.
5.9. Perform In-Process Quality
Control (IPQC) on the
combined granules.
5.10. Add magnesium stearate to
the combined granules and
tumble for 5 minutes.
Date: Date: Date: Page 5 of 6

METHOD AND RECORD

MANUFACTURING INSTRUCTIONS AND RECORD (cont.)
5.11. Compress into tablets using

table-top concave punches
tablet press.
5.12. Every 10 minutes, perform
IPQC tests. Adjust the tablet
compression force as
necessary.
5.13. Calculate theoretical and
actual yield. Account for
losses.
5.14. Perform Finished Product
Quality Control (FPQC).
STANDARD ACCEPTABLE BULK YIELD
Arrange for sample of bulk product to be taken by Q.C. sampler.
Accepted by: _____________
Date: Date: Date:

Page 6 of 6

METHOD AND RECORD

AUTHORIZED DEVIATIONS FROM STANDARD PROCEDURE
PRIOR AUTHORIZATION:
Production: ______________________ QC: ___________________________
Date:_____________________ Date:___________________
NON-STANDARD EVENT RECORD (Include explanation of any non-standard yield):
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: ___________________
QUALITY CONTROL APPROVAL FOR PACKAGING
This bulk batch of ____________________________ has been sampled and tested, and is RELEASED FOR PACKAGING.
Signed:____________________________, Quality Control

Date: ___________________
Date: Date: Date:
Page 1 of 5
BATCH PACKAGING
INSTRUCTIONS AND RECORD


Date: Date:
PACKAGING PERSONNEL
Name Signature Date
Bueno, Samantha Ayessa P.
BULK PRODUCT REQUIRED
MATERIAL QUANTITY BATCH No. ISSUED BY: CHECKED BY:
Placebo Tablets APTCPLX001
Approved by: Checked by: Packaging and Labelling:
Kezia Jahzeel V. Olarve Nathalie Vivielle B. Eleda Samantha Ayessa P. Bueno

Supervisor Quality Assurance Packaging Head
Date: Date: Date:

Page 2 of 5
BATCH PACKAGING

UNIT PACKAGING MATERIALS REQUIRED
MATERIAL CODE QUANTITY BATCH No. ISSUED BY: CHECKED BY:
Sticker paper 30
60 mL wide-mouth 30
amber flint bottles
Black plastic screw-on 30

caps
Aluminum Foil Induction 30

seal liner
(used as cap liners)
PACKAGING LOCATION: Manufacturing Laboratory, 3rd Floor, College of Pharmacy Building, De La Salle Medical and Health
Sciences Institute, City of Dasmariñas, Cavite

Date: Date: Date:
Page 3 of 5
BATCH PACKAGING

PACKAGING INSTRUCTIONS AND RECORD
Name of Operator ___________________Signature_______________ Name of Checker ______________Signature_________
A. LINE CLEARANCE AND CLEANING CHECK

1. Check that the packaging line and equipment are clear of all previous, or any other product, packaging
materials, labels, leaflet instructions, and the like, and that the line and all associated equipment have been
cleaned.
Line Clearance and Cleaning Checked by ____________ Time/Date _________

Confirmed by ____________ Time/Date _________
Record details of previous product and batch packaged on this line:

Previous Product _______________ Batch No. _______________ Signed _____________
B. LABELLING OF PRODUCTS
1. Check that the correct batch code number is printed on the labels.
Batch Code to be printed on labels: APTCPLX001
Checked by _________________________ Time/ Date __________________
2. Paste the labels properly on the 60 mL wide-mouth amber flint bottle with black cap screw on. Ensure that it is
pasted firmly on the bottle
Pasted by _______________________ Time/Date ___________________

Checked by _______________________ Time/Date ___________________

Date: Date: Date:
Page 4 of 5
BATCH PACKAGING

PACKAGING INSTRUCTIONS (cont.)
LABEL SPECIMEN
C. PACKAGING OPERATIONS
1. Check that the general appearance/condition of the bulk product is satisfactory, and that its labeled identity and
batch number are as entered under “Bulk Product Requirement”.
Checked by _______________________ Time/Date __________________
2. Obtain a tablet counter and transfer 100 tablets of Plexcibo to each bottle, attach the printed labels, and
package the product in accordance with applicable SOP.
Checked by _______________________ Time/Date __________________

Date: Date: Date:
Page 5 of 5
BATCH PACKAGING

AUTHORIZED DEVIATIONS FROM STANDARD PROCEDURE:
PRIOR AUTHORIZATION:
Production ____________________ Date ____________
Quality Control _________________ Date ____________
NON-STANDARD EVENT RECORD (Include explanation of any non-standard yield):
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 Date: ____________________________

Approved by: ______________________, Supervisor Date: _____________________________
QUALITY CONTROL APPROVAL FOR PACKAGING
This bulk batch of ____________________, with Batch No. __________________

has been sampled and tested, and is RELEASED FOR PACKAGING.
Signed ________________,Quality Control

Date_______________________________

Date: Date: Date:

QUALITY CONTROL RECORDS SHEET


Date: Date:
CERTIFICATE OF ANALYSIS
IN-PROCESS QUALITY CONTROL RECORD
TEST PARAMETER SPECIFICATIONS ACTUAL RESULT REMARKS
Appearance White granules
Moisture Content 2% moisture
Prepared by: Reviewed by: Approvied by:
Earl Vincent C. Nanali Nathalie Vivielle B. Eleda Kezia Jahzeel V. Olarve

Quality Control Head Quality Assurance Supervisor
Date: Date: Date:


ANGLE OF REPOSE
Height of Cone
Diameter of Cone
Angle of Repose (degrees)
Flow Property
REMARKS/DISPOSITION: ____________________________________________________
Analyzed By: Noted by:
Date: Date:

Date: Date: Date:


PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING
Specification Result
The test sieving analysis is complete when the weight on any

of the test sieves does not change by more than 5% or 0.1 g of
the previous weight on that sieve. If less than 5% of the total
specimen weight is present on a given sieve, the endpoint for
that sieve is increased to a weight change of not more than
20% of the previous weight on that sieve.
Date: Date:

Date: Date: Date:


COMPRESSIBILITY INDEX AND HAUSNER RATIO
V0 (Unsettled apparent volume) Compressibility Flow Character Hausner Ratio

Index (%)
V10 (Volume after 10 taps)
10 Excellent 1.00-1.11
11-15 Good 1.12-1.18
16-20 Fair 1.19-1.25
Compressibility Index (%)
21-25 Passable 1.26-1.34
Hausner Ratio
26-31 Poor 1.35-1.45
Flow Character
32-37 Very poor 1.46-1.59
>38 Very very poor >1.60
Date: Date:

Date: Date: Date:


PARAMETERS SPECIFICATIONS RESULT
Appearance Rounded with high degree of polish
The average tablet weight is not more

Weight than or less than the theoretical tablet
weight + 5%
The tablet thickness is not more than or

Thickness less than the average tablet thickness +
5%.
Hardness A force of about 4 kg is considered the

minimum requirement for a satisfactory
tablet. The tablet hardness of an
uncoated tablet is from 4 to 8kg. The
tablet hardness is not more than or less
than the average tablet hardness + 5%.
Date: Date:

Date: Date: Date:


A. Appearance
Sample Appearance Sampled by: Checked by:
Tablet 1
Tablet 2
Tablet 3
Tablet 4
Tablet 5
Tablet 6
Tablet 7
Tablet 8
Tablet 9
Tablet 10
B. Weight
Sample Weight Sampled by: Checked by:
Tablet 1
Tablet 2
Tablet 3
Tablet 4
Tablet 5
Tablet 6
Tablet 7
Tablet 8
Tablet 9
Tablet 10
Average

Date: Date: Date:

C. Thickness
Sample Thickness Sampled by: Checked by:
Tablet 1
Tablet 2
Tablet 3
Tablet 4
Tablet 5
Tablet 6
Tablet 7
Tablet 8
Tablet 9
Tablet 10
Average

Date: Date: Date:

D. Hardness
Sample Hardness Sampled by: Checked by:

Tablet 1
Tablet 2
Tablet 3
Tablet 4
Tablet 5
Tablet 6
Tablet 7
Tablet 8
Tablet 9
Tablet 10
Average

Date: Date: Date:

CERTIFICATE OF ANALYSIS
FINISHED PRODUCT QUALITY CONTROL RECORD
PARAMETERS SPECIFICATIONS RESULT

Appearance White, round and hiconvex
The average tablet weight is not more than or less

Weight than the theoretical tablet weight + 5%.
The tablet thickness is not more than or less than

Thickness the average tablet thickness + 5%.
Hardness A force of about 4 kg is considered the minimum

requirement for a satisfactory tablet. The tablet
hardness of an uncoated tablet is from 4 to 8kg.
The tablet hardness is not more than or less than
the average tablet hardness + 5%.
Friability Not less than 0.5% or equal to 1% weight loss (after
100 revolutions)
All of the tablets disintegrated completely. If 1 or 2
tablets fail to disintegrate completely, repeat the
Disintegration test on 12 additional tablets. The requirement is met
if not fewer than 16 of the total 18 tablets tested are
disintegrated.

Date: Date: Date:

A. Appearance
Sample Appearance Sampled by: Checked by:
Tablet 1
Tablet 2
Tablet 3
Tablet 4
Tablet 5
Tablet 6
Tablet 7
Tablet 8
Tablet 9
Tablet 10
B. Weight
Sample Weight Sampled by: Checked by:
Tablet 1
Tablet 2
Tablet 3
Tablet 4
Tablet 5
Tablet 6
Tablet 7
Tablet 8
Tablet 9
Tablet 10
Average

Date: Date: Date:

C. Thickness
Sample Thickness Sampled by: Checked by:

Tablet 1
Tablet 2
Tablet 3
Tablet 4
Tablet 5
Tablet 6
Tablet 7
Tablet 8
Tablet 9
Tablet 10
Average

Date: Date: Date:

D. Disintegration
Observation/s:
Performed by:
Checked by:

Date: Date: Date:

E. Friability
Observation/s:
Performed by:
Checked by:

Date: Date: Date:

F. Hardness
Sample Hardness Sampled by: Checked by:

Tablet 1
Tablet 2
Tablet 3
Tablet 4
Tablet 5
Tablet 6
Tablet 7
Tablet 8
Tablet 9
Tablet 10
Average

Date: Date: Date:

Batch Manufacturing Formula, Method and Record: Punctua-Lity (30%) Prepared - Ness (35%) Initiative (35%) Total (100%)

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Batch Manufacturing Formula, Method and Record: Punctua-Lity (30%) Prepared - Ness (35%) Initiative (35%) Total (100%)

Uploaded by

Copyright:

Available Formats

Page 1 of 6

BATCH MANUFACTURING FORMULA,

Product Name: PLEXCIBO Batch No.: APTCPLX001

Form: Tablet Batch Size: 3,000 tablets

PROCESS START AND COMPLETION TIMES

SIGNATURE SPECIMEN AND EVALUATION

Olarve, Kezia Jahzeel V. Supervisor

Eleda, Nathalie Vivielle B. Quality Assurance

Nanali, Earl Vincent C. Quality Control Head

Aguilar, Eionn Philip O. Quality Control

Amistad, Anne Roselle Mae A. Production Head

Rimorin, K-Be B. Production

Vinoya, Paulyne Grace L. Dispensing Head

Bueno, Samantha Ayessa P. Packaging Head

Yarte, Jeyhanz Anthony C. Maintenance

Bagunu, Alain Mariel G. Maintenance

MASTER DOCUMENT EFFECTIVE SUPERSEDES:

Prepared by: Approved by: Production:

Date: Date: Date:

Product Name: PLEXCIBO Batch No.: APTCPLX001

Form: Tablet Batch Size: 3,000 tablets

FORMULA AND WEIGHING RECORD

CODE MATERIAL AMOUNT LOT No. DISPENSED CHECKED

Starch for Starch Paste 82.50 g

Magnesium Stearate 38.50 g

Distilled water for Starch 825.00 mL

Name of Dispenser _______________Signature ____________ Name of Checker _______________ Signature ____________

MAJOR EQUIPMENT: Mixer

Batch document issued by: ______________________________________________ Date: _______________________________

MASTER DOCUMENT EFFECTIVE SUPERSEDES:

Prepared by: Approved by: Production:

Date: Date: Date:

BATCH MANUFACTURING FORMULA,

Product Name: PLEXCIBO Batch No.: APTCPLX001

Form: Tablet Batch Size: 3,000 tablets

MANUFACTURING INSTRUCTIONS AND RECORD

Name of Operator _______________Signature ____________ Name of Checker _______________ Signature ____________

DATE TIME STARTED TIME ENDED OPERATOR CHECKER

1. Check the Plant Log, and enter the

2. Obtain clearance from the

Prod. Supervisor clearance

3. Check the initial temperature.

4. Check initial humidity.

MASTER DOCUMENT EFFECTIVE SUPERSEDES:

Prepared by: Approved by: Production:

Date: Date: Date: Page 4 of 6

BATCH MANUFACTURING FORMULA,

Product Name: PLEXCIBO Batch No.: APTCPLX001

Form: Tablet Batch Size: 3,000 tablets

MANUFACTURING INSTRUCTIONS AND RECORD (cont.)

MASTER DOCUMENT EFFECTIVE SUPERSEDES:

Prepared by: Approved by: Production:

Date: Date: Date: Page 5 of 6

BATCH MANUFACTURING FORMULA,

Product Name: PLEXCIBO Batch No.: APTCPLX001

Form: Tablet Batch Size: 3,000 tablets

MANUFACTURING INSTRUCTIONS AND RECORD (cont.)

5.11. Compress into tablets using

STANDARD ACCEPTABLE BULK YIELD

Arrange for sample of bulk product to be taken by Q.C. sampler.

Accepted by: _____________

MASTER DOCUMENT EFFECTIVE SUPERSEDES:

Name of Dispenser _______Signature Name of Checker _ Signature ______

Batch document issued by: ________________ Date: _

Name of Operator _______Signature Name of Checker _ Signature ______

Name of Operator ___________Signature_ Name of Checker Signature_

Line Clearance and Cleaning Checked by ____ Time/Date _

Checked by _______ Time/ Date

Pasted by _____ Time/Date _

Checked by _____ Time/Date

Checked by _____ Time/Date

Signed: , Production Date: __

This bulk batch of __, with Batch No.