COMPANY NAME BATCH MANUFACTURING RECORD Page: 1 of 8

Department : Title : Batch Record :

Production Tongkat Ali Tablet BMR-001
Name Signature Date
Revision No. :
Prepared by : 0
__________________
Production Manager
Effective Date :
Approved by :
1 January 2016
__________________
QA Manager

1. Product Details
Tongkat Ali 250mg Tablet
Description Colour: Pale
Shape: Round/ Biconvex
Batch size: 53 kg
Batch Quantity
Approx No. tablets: ___________
Packaging Bottle of 60’s
Ambient - conditions, store in tight container protected from light and
Storage Conditions
moisture

2. Production Batch Record Issuance

Issued By – Issuer has reviewed the Batch Record to ensure that the copy is a complete, accurate copy
of the Master Batch Record.

______________________ _____________________________ _________________

(Print) Issued By – Quality Assurance Signature Date
Issued To – Production has reviewed the Batch Record to ensure that the copy is a complete and
correct. Production is responsible for the Batch Record following issuance.

______________________ _____________________________ _________________

(Print) Issued By – Quality Assurance Signature Date

3. Reference Documents
SOP – 002: Non conformances
SOP – 007: Line Clearance
SOP – 010: Temperature and Humidity Monitoring
SOP – 012: Facility Cleaning Procedures
SOP – 015: Material Weighing and Dispensing
SOP – 017: Batch Manufacturing Records
SOP – 019: Tray Oven
SOP – 021: Grinding and Milling Machine
SOP – 022: Cadmill
SOP – 023: Cube Mixer

Batch No: Manufacturing Date : Expiry Date :

TT 1606001 10 July 2016 9 July 2017
 COMPANY NAME BATCH MANUFACTURING RECORD Page: 2 of 8

Department : Title : Batch Record :

Production Tongkat Ali Tablet BMR-001
Name Signature Date
Revision No. :
Prepared by : 0
__________________
Production Manager
Effective Date :
Approved by :
1 January 2016
__________________
QA Manager

SOP – 028: Ribbon Mixer

SOP – 032: B2 Strokes Tablet Press

4. Raw Materials
Quantity
Part Exp/ Performed Verified By
Description Required Lot No. Qty Staged
Number Retest By / Date / Date
(kg)
Eurycoma
R-0122 25.00
Longifolia
Lactose
R-2323 19.34
Monohydrate
Gelatin R-7896 4.80
Corn Starch R-5858 2.40
Methocel R-0326 1.00
Magnesium
R-9696 0.46
Stearate BP/USP

5. Processing Equipments
Previous Calibration Performed By / Verified By /
Equipment Description ID No.
Calibration Required Date Date
Weighing Balance 150 kg WB-01
Tray Oven OT-01
Grinding and Milling
GM-01
Machine
Cube Mixer MX-03
Ribbon Mixer MX-02
Cadmill GM-02
B2 Strokes Tablet Press TP-01
Stainless Steel Container CS-03
Mechanical Sieve (Mesh
SM-01
No: 12)

6. Area Clearance

Batch No: Manufacturing Date : Expiry Date :

TT 1606001 10 July 2016 9 July 2017
 COMPANY NAME BATCH MANUFACTURING RECORD Page: 3 of 8

Department : Title : Batch Record :

Production Tongkat Ali Tablet BMR-001
Name Signature Date
Revision No. :
Prepared by : 0
__________________
Production Manager
Effective Date :
Approved by :
1 January 2016
__________________
QA Manager

Performed By / Verified By /
Step
Date Date
1. GMP Processing Area(s):

Room: ______________________
2. Review the GMP Processing Area Logbook(s) and ensure that the
Logbook(s) is (are) complete, and up-to-date.

3. Review all applicable GMP Processing Area Logbook(s) and verify that
Cleaning has been performed according to Facility Cleaning
Procedures (SOP-011)

Date Cleaning Complete: _____________

4. Review Section 4: Raw Materials, and ensure that it is complete,

accurate, and that all necessary materials are present for the GMP
operation.

5. Ensure that all GMP Materials are Released, Approved and have
sufficient time to the Expiry Date.

6. Review Section 5: Processing Equipment, and ensure that it is

complete, accurate, and that all necessary equipment is present,
cleaned and calibrated, as appropriate.

7. Review the Logbook for each piece of Equipment, and ensure that the
Logbooks are correctly filled out.
Tray Oven (OT-01) : ___________
Grinding and Milling Machine (GM-01) : ___________
Cube Mixer (MX-03) : ___________
Ribbon Mixer (MX-02) : ___________
B2 Strokes Tablet Press (TP-01) : ___________
8. Verify that the Production Area does not contain any items from
previous batches or cleaning activities and that no items unrelated to
the current batch are present.

9. Area Clearance Complete.

QA shall Complete the Area Clearance Sign (SOP-007, Attachment 1)

and affix it to the GMP Processing Area entrance.

Batch No: Manufacturing Date : Expiry Date :

TT 1606001 10 July 2016 9 July 2017
 COMPANY NAME BATCH MANUFACTURING RECORD Page: 4 of 8

Department : Title : Batch Record :

Production Tongkat Ali Tablet BMR-001
Name Signature Date
Revision No. :
Prepared by : 0
__________________
Production Manager
Effective Date :
Approved by :
1 January 2016
__________________
QA Manager

7. Production Procedure
Performed Verified By
Processing Step
By / Date / Date
A. Dispensing & Raw Material Preparation
Location: Dispensing Room 1

1. Ensure room Temperature is within 22-24°C and Humidity is less than

65%

2. Weigh the ALL Raw Materials (RM) as mentioned in Part 4 separately

into a suitable container/ plastic bags in.

Label each of the container/ bags with

a) Name of RM
b) Lot No.

3. Wash Eurycoma longifolia (Tongkat Ali) with RO water and dry in Tray
Oven (ID: OT-01) at 60°C for 8 hours.

Temperature: ________ °C Time Start: ________ Time Stop: ________

4. Crush/powder the dry Eurycoma longifolia (Tongkat Ali) into fine powder
with Grinding and Milling Machine (ID: GM-01).

B. Mixing
Location: Mixing Room 2

5. Ensure room Temperature is within 22-24°C and Humidity is less than

65%
Temperature: _________ Humidity: ________

6. Mix Eurycoma longifolia powder, Lactose and Corn Starch in Cube

Mixer (ID: MX-03) for 5 mins.
Time Start: ________ Time Stop: ________

7. Transfer all the contents of Cube Mixer (ID: MX-03) into a suitable
container/ plastic bags.

8. Label the plastic bag with

a) “Tongkat Ali A Blend”
Batch No: Manufacturing Date : Expiry Date :
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 COMPANY NAME BATCH MANUFACTURING RECORD Page: 5 of 8

Department : Title : Batch Record :

Production Tongkat Ali Tablet BMR-001
Name Signature Date
Revision No. :
Prepared by : 0
__________________
Production Manager
Effective Date :
Approved by :
1 January 2016
__________________
QA Manager

b) Batch No.

9. “Transfer Tongkat Ali A Blend” into Ribbon Mixer (ID: MX-02).

10. Blend for 3 mins at speed no: 3.

Speed No: ________ Time Start: ________ Time Stop: ________

11. Dissolve Gelatin with hot water in a Stainless Steel Container (ID: CS-
03).

12. Pour the “Dissolved Gelatin” into the powder, granulate for 5 mins at
speed no: 3..
Speed No: ________ Time Start: ________ Time Stop: ________

13. Transfer all the contents of Ribbon Mixer (ID: MX-02) into Cadmill (ID:
GM-02). Operate the machine according the SOP-022.

14. Dry the granules at 60°C for 6 hours in Tray Oven (ID: OT-01).
Temperature: ______ °C Time Start: ________ Time Stop: ________

15. Sieve into fine powder with Mechanical Siever (Mesh No: 12)

16. Transfer the fine powder into Cube Mixer (ID: MX-03), add in
Magnesium Stearate and mix for 10 minutes at speed no: 3.
Speed No: ________ Time Start: ________ Time Stop: ________

17. Transfer the contents of the Cube Mixer into a suitable plastic bag.

18. Label the plastic bag

a) “Blend for Tableting: Tongkat Ali”
b) Batch No

C. Tableting

19. Ensure room Temperature is within 22-24°C and Humidity is less than
65%
Temperature: _________ Humidity: ________

Batch No: Manufacturing Date : Expiry Date :

TT 1606001 10 July 2016 9 July 2017
 COMPANY NAME BATCH MANUFACTURING RECORD Page: 6 of 8

Department : Title : Batch Record :

Production Tongkat Ali Tablet BMR-001
Name Signature Date
Revision No. :
Prepared by : 0
__________________
Production Manager
Effective Date :
Approved by :
1 January 2016
__________________
QA Manager

Monitor both Temperature and Humidity every 30 mins until end of Tableting Process

Time Temperature (°C) Humidity (%)

20. Set-up the tablet press with the hopper and feed frame as described in
SOP-032. Use Punches and Dies ID: 123456
Punches and Dies ID: __________

21. Ensure that the gap between the feed frame and the die table is paper
thick

22. Carefully pour the material (Blend for Tableting: Tongkat Ali) into the
feed frame of the tablet press.

23. Manually operate/rotate the tablet press to ensure that the feed frame is
evenly filled with the granules and flow well onto the die table and die
cavity.

24. Continue the rotation to produce a couple of tablets - ensure that all the
parts of the press are working (SOP-032).
Target weight: 250 mg; Target weight range: 240 – 460mg

25. Set machine at speed no: 2.

26. Turn on the tablet press (as described in SOP-032) and allow the
machine to stabilize i.e. discard first 5 tablets and check the weight of
the next 2 tablets.
Target weight: 250 mg; Target weight range: 240 – 460mg

27. Collect tablets until the end of production. Transfer these tablets into
containers and label “Tongkat Ali Tablet”

28. At the end of the run perform cleaning according the SOP-012.

D. Film Coating

Batch No: Manufacturing Date : Expiry Date :

TT 1606001 10 July 2016 9 July 2017
 COMPANY NAME BATCH MANUFACTURING RECORD Page: 7 of 8

Department : Title : Batch Record :

Production Tongkat Ali Tablet BMR-001
Name Signature Date
Revision No. :
Prepared by : 0
__________________
Production Manager
Effective Date :
Approved by :
1 January 2016
__________________
QA Manager

…Cont…
E. Packing & Labelling
…Cont…
8. Sampling, Material Transfer & Storage

9. Yield Calculation

Yield
= 100 % x Weight of Tablets
Weight of Raw Materials
= _______ (Specification: 95 - 100 %)

Finished Product Yield

= 100% x No. of Goods produced at the end of process + Rejects + Samples + Returned
No. of Goods received at the start of process
= __________ (Specification: 90 - 100 %)

10. Post-Production Review

The complete Post-Production Batch Record has been reviewed for completeness and accuracy. All
pages are complete and all entries conform to Good Documentation Practices.

Name Signature Date

Production
Quality Assurance

Batch No: Manufacturing Date : Expiry Date :

TT 1606001 10 July 2016 9 July 2017
 COMPANY NAME BATCH MANUFACTURING RECORD Page: 8 of 8

Department : Title : Batch Record :

Production Tongkat Ali Tablet BMR-001
Name Signature Date
Revision No. :
Prepared by : 0
__________________
Production Manager
Effective Date :
Approved by :
1 January 2016
__________________
QA Manager

11. Product Release

The material produced through the execution of this Batch Record shall be Dispositioned by QA
according to Product Release Procedure (SOP-010).

The product conforms to Finished Goods Specification: Tongkat Ali Tablet (FG 0333).

COA No: ___________ Date: ____________

The Disposition shall be recorded below.

Name Signature Date

Production
Quality Control
Quality Assuarance

Batch No: Manufacturing Date : Expiry Date :

TT 1606001 10 July 2016 9 July 2017
 UNIVERSITY OF Batch Record Supersedes: Version:
MARYLAND
School of Pharmacy MBR-046 New 1.0
Title: Fexo A – Fexofenadine HCl tablets Effective: Page 6 of 17
60mg (F-7046)

6. Review Section 7: Processing Equipment, and ensure that it is

complete, accurate, and that all necessary equipment is present,
cleaned and calibrated, as appropriate.
Review the Logbook for each piece of GMP Equipment, and
ensure that the Logbooks are correctly filled out.
Fluid bed (UMB-00 ) - ____________
Twin shell blender (UMB-00 ) –____________
B2-Stokes tablet press (UMB-0013) –____________
7. Verify that the cGMP Processing Area does not contain any items
from previous batches or cleaning activities and that no items
unrelated to the current cGMP batch are present.
8. Area Clearance Complete.
QA shall Complete the Area Clearance Sign (SOP-021,
Attachment 1) and affix it to the GMP Processing Area entrance.

9. Production Procedure Performed Verified By

Processing Step By / Date / Date

Lot Number:
Biopharmaceutical Development Program F
Master Production Record (MPR)
Production of
Section : Final Filtration Using a 0.22µm Filter
Document No. Project No. Lot No. Location Revision E

MPR-P-

1.1.1.1 Integrity test the 0.22 µm filter used for final filtration as per SOP . Verify that the
filter that was used for filtration in Section . The bubble point of the filter must exc
specifications. If the results of the integrity test do not meet specifications, repeat Secti
filter. Record details of additional filtering and integrity tests in the comments section.

Serial # of Filter:

Date/Time of Testing: _

Bubble Point of Filter: _ psig

Results of Integrity Test Meet Specifications (Y/N):

Performed By: Date: Verified By:

1.2 Distribution of Product

1.2.1 If the “ ” will be stored in one container as a bulk, complete the remaining pages of th
will be distributed for storage, proceed to the “Bulk, Aliquoting, Sampling and Storage” sec
the remaining pages of this BPR.

Product will be distributed (Y/N):

Performed By: Date: Verified By:

This document is made available through federal funds from the National Cancer Institute, NIH, under contract H
 UNIVERSITY OF Batch Record Supersedes: Version:
MARYLAND
School of Pharmacy MBR-046 New 1.0
Title: Fexo A – Fexofenadine HCl tablets Effective: Page 7 of 17
60mg (F-7046)

9. Production Procedure Performed Verified By

Processing Step By / Date / Date

1. Weigh the API and excipients separately into a suitable

container/plastic bags in Room 670. Check for lumps
and screen the material if required using an 18 mesh
screen.
Fexofenadine Hydrochloride (R-1057) – 15%
Required 52.5 gm; Weighed ________gm.

Avicel PH 102 (Microcrystalline cellulose) (R-1002) - 38.63%

Required 135.21 gm; Weighed ________gm.

Lactose 110M (Lactose monohydrate) (R-1012) – 38.63%

Required 135.21 gm; Weighed ________gm.

Ac-Di-Sol (Croscarmellose Na) (R-1016) – 1.25%

Required 4.38 gm; Weighed ________gm.

Kollidon K-30 (Polyvinyl pyrollidone) (R-1013) – 6.5%

Note: 15% w/w solution in sterile water

Required 151.67 gm; Sprayed ________gm.

Total weight of the blend (excluding the weight of the

extragranular fraction)

Label the container/bags - “Fexofenadine blend – Formulation A”

2. Carefully transfer ALL the weighed materials into 8qt V-

twin shell blender i.e blender UMB-00 check the fill
volume once ALL the materials are transferred to the
twin shell blender container. Fill volume _______%
(visual inspection).
If the fill volume is 40 to 70% of the blender - proceed to
blending step (Step 6)
3. Blend for 5 min:
Start Time: ______min; End Time: _______min

Lot Number:
Biopharmaceutical Development Program F
Master Production Record (MPR)
Production of
Section : Final Filtration Using a 0.22µm Filter
Document No. Project No. Lot No. Location Revision E

MPR-P-

1.3.3 Submit the samples to QC for testing and enter the QC test request numbers in the t
product samples at °C. Include the QC Request Verification as described in the tabl

QC Request Test Specification

Test SOP Number/Vendor Sample Volume, mL
Number (If Required)

Performed By: Date:

This document is made available through federal funds from the National Cancer Institute, NIH, under contract H
 UNIVERSITY OF Batch Record Supersedes: Version:
MARYLAND
School of Pharmacy MBR-046 New 1.0
Title: Fexo A – Fexofenadine HCl tablets Effective: Page 14 of 17
60mg (F-7046)

9. Production Procedure Performed Verified By

Processing Step By / Date / Date

39. Turn on the tablet press, allow the machine to stabilize

i.e. discard first 5 tablets and check the weight of the
next 2 tablets. Adjust the height of the weight control
cam to make 470+10 mg tablets.
40. Using the transducers and software (National
instruments) adjust the compression force to ______mV.
41. Throughout the collection time monitor and ensure that
the compression force is within limits (Step 43).
42. Collect tablets until the end of production. Transfer these
tablets into previously labeled containers “Fexo A-
Fexofenadine Hydrochloride USP 60 mg”
43. At the end of the run perform cleaning according the
SOP-027
10. Post-Production Sampling, Material Transfer and Storage

11. Yield Calculations

Granulation Yield
Yield =100 x weight of granulation
weight of powder (350 gm)

Yield = ______________________

Lot Number:
Biopharmaceutical Development Program F
Master Production Record (MPR)
Production of
Section : Final Filtration Using a 0.22µm Filter
Document No. Project No. Lot No. Location Revision E

MPR-P-

Comments:

Reviewed By Purification Manager: Date

This document is made available through federal funds from the National Cancer Institute, NIH, under contract H
 UNIVERSITY OF Batch Record Supersedes: Version:
MARYLAND
School of Pharmacy MBR-046 New 1.0
Title: Fexo A – Fexofenadine HCl tablets Effective: Page 16 of 17
60mg (F-7046)

13. Exception Log

Record all Exceptions that occur during the production process. Quality Assurance shall
review, classify, initial and date each entry following production, or as required. Planned
Deviations and Nonconformances require a documented Nonconformance Report according
to Nonconformances (SOP-005).

Documented Class QA Verified

Exception By / Date By / Date
(E, PD, NC)

1.

2. .

3. .

4.

5.

6.

7.

8.

9.

10.

E = Exception
PD = Planned Deviation
NC = Nonconformance

Lot Number:
Lonza Batch Record Effective Date: __________

Document Number: __________ Version: __________ Printed by: __________

Batch ID: __________

Passage 2 – Expansion from 8 x T-225 Flasks to 2 x CELLSTACK10

N/A Material Description Part Number Qty Control Number Use By Date

Passage 2 Materials Section | Controlled Copy Number: ______ | Printed on: __________ | Page 1/60

Lonza Batch Record Effective Date: __________

Document Number: __________ Version: __________ Printed by: __________

Batch ID: __________

Centrifugation Parameters

Speed (RPM) Duration Temperature Rotor Type Balance Check

Centrifugation Section | Controlled Copy Number: ______ | Printed on: __________ | Page 8/60

Lonza Batch Record Effective Date: __________

Document Number: __________ Version: __________ Printed by: __________

Batch ID: __________

Transfection Process Details

Reagent Name Lot Number Volume Storage Conditions Expiry Date

Transfection Section | Controlled Copy Number: ______ | Printed on: __________ | Page 15/60

Lonza Batch Record Effective Date: __________

Document Number: __________ Version: __________ Printed by: __________

Batch ID: __________

Harvest Process Records

Sample ID Collection Time Operator Verification Comments

Harvest Section | Controlled Copy Number: ______ | Printed on: __________ | Page 22/60