Batch Record Date: Apr 15, 2024

Version: 01
Manufacturing of 100 mg Ibuprofen Tablets
Page: 1 of 8

Batch size: 1,000 tablets

Batch Record

Ibuprofen
100 mg
Immediate Release Tablets

Step Function Name Date Signature

Process
Prepared Development
Manager

Head of Process Devel-

Reviewed
opment

Head of
Approved
Manufacturing

Head of Quality Manage-

Approved
ment

Form: Master Batch Record, Version 07, Nov 23, 2024

 Batch Record Date: Apr 15, 2024

Version: 01
Manufacturing of 100 mg Ibuprofen Tablets
Page: 2 of 8

Batch size: 1,000 tablets

A. Introduction
The following master batch record describes the manufacturing of 100 mg Ibuprofen tablets
using a rotary tablet press.

Form: Master Batch Record, Version 07, Nov 23, 2024

 Batch Record Date: Apr 15, 2024

Version: 01
Manufacturing of 100 mg Ibuprofen Tablets
Page: 3 of 8

Batch size: 1,000 tablets

B. Responsibilities
Tab. 1: Responsibilities

Function Responsibilities Name Sign

Manufacturing of the product, Student name
Production cleaning of the manufacturing
equipment
Manufacturing of the product, Student name
Production cleaning of the manufacturing
equipment
Sampling of IPC and the finished Student name
Quality Control
products

C. Related Documents
Tab. 2: Releated Document

Code Title Version

Manufacturing of process development batches on pilot-scale manufacturing
SOP073 3
equipment
SOP043 Cleaning of IMA pressima rotary tablet press equipment 2

D. Master Batch Formula

Tab. 3: Master Batch Formula
Amount Amount Amont
Shelf
Name Function Company Lot No. (tablet) (tablet) (batch)
Life
(w/w) [%] [mg] [g]
Ibuprofen API FunnyPharm

Total:

E. Materials
Tab. 4: Equipment

Name Function Company Qualification Status*

IMA Pressima Rotary Tablet Press IMA
Balance Mettler-Toledo

*state date or NQ for not qualified

Form: Master Batch Record, Version 07, Nov 23, 2024

 Batch Record Date: Apr 15, 2024

Version: 01
Manufacturing of 100 mg Ibuprofen Tablets
Page: 4 of 8

Batch size: 1,000 tablets

Tab. 5: Raw Material Allocation

Release Amount
Lot Name Function Company
Status* [g]
Ibuprofen API FunnyPharma Q

*F=Free, Q=Quarantine or R=Rejected

F. Manufacturing
Process Step Check
No. Step (sign)
Person 1 Person 2
Start of Manufacturing [MMM DD, YYYY, TT:TT]:
1
___ ___ ___. ___ ___ , ___ ___ ___ ___ , ___ ___ : ___ ___

F.1 Preparation of the rotary tablet press

Process Step Check
No. Step (sign)
Person 1 Person 2
Check whether all parts of the rotary press are present.

All parts are present.

1
Not all parts are present.*

*Contact head of manufacturing and wait for further instructions.

Check whether all parts of the rotary press are clean.

All parts are clean.

2
Not all parts are clean.*

*Contact head of manufacturing and wait for further instructions.

Assemble the rotary press according to the instructions in the rotary
3
press manual (version 3, 2018) pp. 120 – 180.

Form: Master Batch Record, Version 07, Nov 23, 2024

 Batch Record Date: Apr 15, 2024

Version: 01
Manufacturing of 100 mg Ibuprofen Tablets
Page: 5 of 8

Batch size: 1,000 tablets

F.2 Preparation of the powder mixture

Process Step Check
No. Step (Sign)
Person 1 Person 2
Check whether all substances are present.

All parts are present.

1
Not all parts are present.*

*Contact head of manufacturing and wait for further instructions.

2 Note down the shelf life in tab. 1
3 Note down the Lot number in tab. 1
Label a weighing vessel with module code, experiment number and
4
group number
Weigh in the requirement amount of substance A into the weighing
vessel.

Balance No.: _______________

5

Weighed amount Substance A [g]: _______________

Weigh in the requirement amount of substance B into the weighing

vessel.

Balance No.: _______________

6

Weighed amount Substance B [g]: _______________

Weigh in the requirement amount of substance C into the weighing

vessel.

Balance No.: _______________

6

Weighed amount Substance C [g]: _______________

F.3 Tableting
Process Step Check
No. Step (Sign)
Person 1 Person 2
Adjust the process parameter to the following settings:
1

Form: Master Batch Record, Version 07, Nov 23, 2024

 Batch Record Date: Apr 15, 2024

Version: 01
Manufacturing of 100 mg Ibuprofen Tablets
Page: 6 of 8

Batch size: 1,000 tablets

Process Step Check

No. Step (Sign)
Person 1 Person 2
3
Take an In-Process Control of 10 tablets, every 2 min. Document the
4
sampling in appendix 1.
5
6
Determine the number of tablets manufactured.
7
Number of tablets manufactured: _______________

Process Step Check

No. Step (sign)
Person 1 Person 2
End of Manufacturing [MMM DD, YYYY, TT:TT]:
1
___ ___ ___. ___ ___ , ___ ___ ___ ___ , ___ ___ : ___ ___

Form: Master Batch Record, Version 07, Nov 23, 2024

 Batch Record Date: Apr 15, 2024

Version: 01
Manufacturing of 100 mg Ibuprofen Tablets
Page: 7 of 8

Batch size: 1,000 tablets

G. Balancing
Tab. 6: Balancing
Amount Amount Balance Balance within
Lot Name Company
(end) [g] (used) [g] [%] limits?*
Ibuprofen FunnyPharma yes no
yes no
yes no
*
0.5% is acceptable

Process Step Check

No. Step (Sign)
Person 1 Person 2
1 Document the raw material flow by filling in the balance table (tab. 6)
Fill in “Amount (end)” by weighing the residual amount of the respec-
2
tive raw material.
Fill in “Amount (used)” by using the amount of the raw material from
3
tab. 3 master batch formula.
Calculate the “Balance” by using the following formula.

4 100 %
Difference [% ]= × Amount ( used )−100 %
Amount (end )

Check whether all raw materials are accounted for.

All raw materials are within 0.5%.

5
Not all materials are within 0.5%.*

*Contact head of manufacturing and wait for further instructions.

H. Line Clearance
Process Step Check
No. Step (Sign)
Person 1 Person 2
Disassemble the rotary tablet press according to the instructions in the
1
manual (version 3, 2018) pp. 205 – 245.
Clean the rotary press according to the instructions in the manual (ver-
2
sion 3, 2018) pp. 255 – 275.
Clean all surfaces in the workspace according to the cleaning instruc-
3
tions for the room (SOP371).
4 Empty all trash bins

Form: Master Batch Record, Version 07, Nov 23, 2024

 Batch Record Date: Apr 15, 2024

Version: 01
Manufacturing of 100 mg Ibuprofen Tablets
Page: 8 of 8

Batch size: 1,000 tablets

I. Yield
Process Step Check
No. Step (Sign)
Person 1 Person 2
1
2
3
4
5

J. GMP-Statement and Approval

Function Statement and Approval

I hereby state that the manufacturing of the batch was conducted under
GMP. All deviations were documented, and no deviation was severe
enough to aboard the manufacturing of the batch.
Head of Manufacturing

__________________________________
Date and Signature Head of Manufacturing

I hereby state that the sampling of the In-Process Controls was conducted
under GMP. All deviations were documented, and no deviation was severe
enough to aboard the manufacturing of the batch.
Head of Quality Control

__________________________________
Date and Signature Head of Quality Control

K. Document History
Version Comment Date

1 Initial preparation Apr 15, 2024

Form: Master Batch Record, Version 07, Nov 23, 2024