Page No.

35 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

Batch Quantity : 30 kg COMPOSITION:

Packaging : Blister, @10 Each Tablet : Celecoxib 200 mg

Capsules
Contains

: White

Color : Capsule

Shape

Mfg. Date : 22 Februari 2022

Document issued by: Issuer has reviewed the
Batch Record to ensure that the copy is a
complete, accurate copyof the Master Batch
Record
Date
Document Received by: 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
 Date:

This Document Supersedes : None

Mfg. Licence No. : XXXX/XX/XXX Material code No. – XXXXXXXX

Storage Condition : Store in cool, dry & dark place, 15-30°C.

Marketed by : PT. Farindus Pharmaceuticals

Serial No. : XXX / XXX/ XXX

Reference Documents

SOP - ………. : ………………………………………………

SOP - ………. : ………………………………………………

SOP - ………. : ………………………………………………

Area Used :

Previous Product Processed :

Checked by Pharmacist :

Date

This batch has/has not been completed according to the instructions given in M.F.R. No.

XX/XXX/00. Deviation sheet attached: Y/N

Actual Yield: Capsules Date of Packing:

Retworking Generated: _ Kg Quantity:

Total

Yield: %

Final BMR Checked by: Final BMR Checked by:

Date: Date:
 Prepared By Checked By Reviewed By Approved By

Quality Assurance Production Production Head QA & QC Head

Date: Date: Date: Date:

 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

GENERAL INSTRUCTION FOR

MANUFACTURING
Prosedur Produksi Skala Pilot:

1. Dikalsium fosfat dihidrat, natrium dodesil sulfat dan crospovidone diayak secara terpisah dengan 
Russels Compact Sieves hingga diperoleh ukuran partikel 400 mikron. Celecoxib diayak dengan
menggunakan alat yang sama sehingga diperoleh ukuran partikel 1410 mikron.

2. Semua bahan baku ditimbang secara terpisah ke dalam wadah/kantong plastik yang sesuai menggunakan
timbangan Mettler Toledo BBA238-BCC600R/S, kapasitas 15 kg.
3. Beri label pada setiap wadah/kantong dengan

a) Nama bahan baku

b) No. Lot

4. Polivinilpirolidon K 30 dan Polivinilpirolidon K 90 dilarutkan dengan Purified water pada suhu 25° C
(IPC: Homogenitas) kemudian ditandai sebagai campuran 1 (M1).

5. Dikalsium fosfat dihidrat, natrium dodesil sulfat, crospovidone dan celecoxib dipindahkan ke granulator
mixer geser tinggi (High Shear Mixer Granulator), dicampur dan digranulasi dengan bahan M1 pada
kecepatan pencampuran 150 rpm dan kecepatan granulasi 2000 rpm selama 360 detik (IPC :
Homogenitas). Campuran ini ditandai sebagai campuran 2 (M2).
6. Butiran Butiran basah dari M2 dikeringkan bertahap atau setengahnya dalam fluid bed dryer, digiling bersama dengan kecepatan
30 rpm dan kemudian dikeringkan dalam fluid bed dryer pada suhu 65 ± 5° C.
7. Butiran kering langkah 6 diayak hingga diperoleh ukuran partikel diantara < 600 mikron (no. mesh 30).
8. Bahan langkah 7 dipindahkan ke bin blender kemudian dicampurkan  Magnesium stearat dengan kecepatan
15 rpm selama 10 menit sehingga diperoleh masa akhir granul (IPC : Homogenitas).
9. Dilakukan evaluasi pada massa granul berupa kadar lembab, kompresibilitas dan sifat alir.
10. Bahan dari langkah 8 diisi dalam kapsul gelatin keras ukuran 2 dengan menggunakan mesin pengisi
kapsul otomatis (Automatic capsule filling machine) dan dilanjutkan ke tahap polishing dengan
menggunakan mesin polishing (Polishing machine).
11. Dilakukan evaluasi akhir meliputi keragaman bobot, waktu hancur dan disolusi pada kapsul.
12. Dilakukan pengemasan primer menggunakan alat pengemasan primer (Blister Packing machine),
kemudian dilakukan evaluasi kebocoran strip, penandaan dan penampilan.
13. Dilakukan pengemasan sekunder dan pengisian leaflet produk dengan menggunakan mesin
pengemas karton otomatis (Automatic cartoning machine).
 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

PROCESSING EQUIPMENT

Sr. Previous Calibration Verified By /

Performed By /
No. Machinery /Equipment ID No. Calibration Required Date
Date
1. Metler toledo bench scale
BBA238-8A3R/S
2. Russel compact sieves 15/10/21 30/11/22
3. High sear mixer 30/11/22
. granulator 15/10/21
4. Fluid bed dryer 15/10/21 30/11/22
5. Automatic capsule filling 15/10/21 30/11/22
machine
6. Bin Blender 15/10/21 30/11/22
7.
Blister packing machine 15/10/21 30/11/22

8.
Automatic cartoning 15/10/21 30/11/22
machine
13. Moisture Analizer 15/10/21 30/11/22
9. Timbangan
14. Capsul polisher
Analitik 15/10/21
15/10/21 30/11/22
30/11/22
10. Dissolution tester 15/10/21 30/11/22
11. HPLC 15/10/21 30/11/22
12. Tap density apparatus 15/10/21 30/11/22
 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

CLEANING RECORD OF MACHINERY & EQUIPMENT

Sr. Machinery /Equipment Capacity Equipment Previous Chd. Re-Chd.

Cleaned
No. No. Product On By By/ by/Date
& B. No. Date
1. Metler toledo bench scale
BBA238-8A3R/S

2. Russel compact sieves

3. High sear mixer granulator -

4. Fluid bed dryer
5. Automatic capsule filling
machine
6. Bin Blender

7. Blister packing
machine
8. Automatic cartoning
machine
9. Capsul polisher
10. Dissolution tester
11. HPLC
12. Tap density apparatus
13. Moisture Analizer
14. Timbangan Analitik
 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

CLEANING AREA

Verified By /Date Re-

No. Step
Chd. By /Date
Chd. by/Date

1. Review GMP Processing Area:

Room:
2. Review Processing Area and ensure
that complete, and up-to-date
3. Review all applicable Processing
Area and verify that Cleaning
has been performed according to
Facility Cleaning Procedures
(SOP...............)

Date Cleaning Complete:

4. Review Raw Materials, and ensure
that it is complete, accurate, and
that all necessary materials are
present for the operation
5. Ensure that all GMP Materials
are Released, Approved and have
sufficient time to the Expiry Date

6. Review Processing Equipment,

and ensure that it is complete,
accurate, and that all necessary
equipment is present,cleaned and
calibrated, as appropriate
7. That the Logbooks are correctly
filled out.
SOP - ……….
SOP - ……….
SOP - ……….
SOP - ……….
8. Verify that the production Area
does not contain any items from
previous bathces 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-…….,
Attachment 1)
 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

BILL OF RAW MATERIALS & WEIGHING RECORD

Sr Ingredients Qty /Tab Qty for A. R. Bal. Gross Tare Net W Wtd Chkd.
No (mg) Batch (kg) No./Date No. Wt.(kg) Wt (kg) By By
(kg)

1. Celecoxib
Part Number:
Mfg. Date: 200 6
Exp. Date:
2. Dicalcium
Phosphate
Dihydrate
Part Number: ad
ad
Mfg. Date: 10 30
Exp. Date: 00

3. Sodium Dodecyl
Sulfate
Part Number: 12,5 0,3
75
Mfg. Date:
 Exp. Date:

4.
Crospovi
done 25 0,75

Part
Number:

Mfg.
Date:
5.
Polyvinyl
pyrrolido
ne K 30
25 0,7
Part Number: 5
Mfg. Date:
Exp. Date:
6.
Polyvinylpyrroli

done K 90 15 0,45
Part Number:
Mfg. Date:
Exp. Date:
7. Purified Water

Part Number:
Mfg. 1,2 0,036

Date: Exp.
Date:
8. Magnesium
stearat

Part Number: 10 0,3

Mfg. Date:
Exp. Date:
Compression Weight : 1000 mg/tablet

Requisition Given By: Date:

Area Cleanliness Production Pharmacist: Date:

Cheched by:
Stores Supervisor: Date:

Previous Product Processed: B. No.:

Material Required On: Issued On:

Calculation Checked By:

Production: Date:

Q.A.: Date:
 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

PRODUCTION PROCEDURE SHEET

Date & Time of

Operation
Sr. No Operation Operation
From To Done By Chd. By
A. DISPENSING & RAW MATERIAL PREPARATION

Location: Kelas E

1.0 Pastikan suhu ruangan dalam 22-25oC dan

kelembapan kurang dari 65%

Suhu o
C Kelembapan %

1.1 Shifting: Refer SOP No. XX/XX/000

Ayak semua bahan baku secara terpisah

dengan ayakan yang sesuai.
Dikalsium fosfat dihidrat mesh

no. 40

Celecoxib mesh no. 14

PVP K 30 mesh no. 60

PVP K 90 mesh no. 60

Sodium Dodecyl Sulfate mesh no.

Crospovidone mesh no.

Magnesium stearate mesh no. 60

Beri label pada setiap wadah/kantong dengan

a) Nama bahan baku
b) No. Lot
PROCESSING STEP

B. MIXING

Location: Kelas E

2.0 Pastikan Suhu ruangan dalam 22-25 °C dan

Kelembapan kurang dari 40%

Suhu: °C Kelembapan: %

2.1 Mixing: Refer SOP NO: XX/XX/000

Dikalsium fosfat dihidrat, natrium dodesil sulfat,

crospovidone dan celecoxib dipindahkan ke
granulator mixer geser tinggi (High Shear Mixer
Granulator), dicampur dan digranulasi dengan
bahan M1 pada kecepatan pencampuran 150
rpm dan kecepatan granulasi 2000 rpm selama
360 detik (IPC : Homogenitas). Campuran ini
ditandai sebagai campuran 2 (M2)..

Volume isi % (inspeksi visual)

2.2 Butiran basah dari M2 dikeringkan bertahap atau
setengahnya dalam fluid bed dryer, digiling
bersama dengan kecepatan 30 rpm dan kemudian
dikeringkan dalam fluid bed dryer pada suhu 65 ±
5° C
 Kecepatan: rpm

Waktu mulai: menit

Waktu berhenti: menit

2.3
Butiran kering langkah 6 diayak hingga diperoleh
ukuran partikel diantara < 600 mikron (no. mesh
30).
Volume isi % (inspeksi visual)
2.4 Masukkan Bahan langkah 7 dipindahkan ke bin
blender kemudian dicampurkan  Magnesium
stearat dengan kecepatan 15 rpm selama 10
menit sehingga diperoleh masa akhir granul
(IPC : Homogenitas).

Kecepatan: rpm

Waktu mulai: menit

Waktu berhenti: menit

Volume isi % (inspeksi visual)

2.5
Dilakukan evaluasi pada

massa granul berupa kadar

lembab, kompresibilitas dan

sifat alir.

Volume isi % (inspeksi visual)

C. TABLETING

Location: Mixing Room 3 (Kelas E)

3.0 Pastikan Suhu ruangan dalam 22-25 °C dan

Kelembapan kurang dari 40%

Suhu: °C Kelembapan: %

Pantau Suhu dan Kelembapan setiap 30 menit

hingga Proses Tableting berakhir

3.1 Capsuling: Refer SOP NO: XX/XX/000

Bahan dari langkah 8 diisi dalam kapsul gelatin

keras ukuran 2 dengan menggunakan mesin
pengisi kapsul otomatis (Automatic capsule filling
machine) dan dilanjutkan ke tahap polishing
dengan menggunakan mesin polishing (Polishing
machine).

3.2 Dilakukan evaluasi akhir meliputi keragaman

bobot, waktu hancur dan disolusi pada kapsul.
 3.10 Di akhir proses, lakukan pembersihan.

D. PACKAGING & LABELING

Location: Packing Room 4

4.0 Pastikan Suhu ruangan dalam 22-25°C dan

Kelembapan kurang dari 40%

Suhu: °C Kelembapan: %

4.1 Packaging: Refer SOP NO: XX/XX/000

Dilakukan pengemasan primer

menggunakan alat pengemasan primer
(Blister Packing machine), kemudian
dilakukan evaluasi kebocoran strip,
penandaan dan penampilan.

4.2 Beberapa blisters tablet diambil untuk evaluasi

kemasan primer

QC Departement……………………………

Date ……………………………………
4.3 Dilakukan pengemasan sekunder dan pengisian
leaflet produk dengan menggunakan mesin
pengemas karton otomatis (Automatic cartoning
machine).

4.4 Beberapa blisters kapsul diambil untuk

evaluasi kemasan primer

QC Departement……………………………

Date ……………………………………
4.5 Di akhir proses, lakukan pembersihan.
 Page No. 37 of 16

BATCH MANUFACTURING
RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date
Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022
Batch No. : B 22001 M.F.R. Revision 00
No & Date

IN PROCESS
CONTROL
Balance ID No.:
Date of Compression Shift I II II
M/C Used Operator
No. of Punches Punches Used
Theoretical Weight of Wt. Variation
+/- …………% of 20T
…….. Capsules Limit

Time Actual Wt. of 20 Disintegration Disolusi Penetapan Signature Chd.

Kadar
Capsules Time Operator by

Standar : 990- Standar : < 15 Standar : < Standar : 90-

110%
1010 mg menit 30 mins
 …………… mg NMT ……. sec NLT …….. ……………. mm
Kg/cm2
………….. %

L R L R L R L R

Check & record the weight of 20 Capsules every 15 minutes.

Check & record the average hardness of 3 Capsules & average thickness of 3 Capsules every 30 min.
Check & record the D.T. of 6 Capsules, weight variation & friability of Capsules every 2 hours
 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

WEIGHT VARIATION RECORD

Machine ID No.: Balance ID No.:

Date: Shift: Wt. variation Limit......................% of Avg. Wt.

Wt. of 20 Capsules g g g g g g g G G

Avg. Wt of Tab mg mg mg mg mg mg mg Mg Mg

Time in hour

Weight of Individual Capsules in mg

Waktu Hancur Test

1.

2.

3.

4.
5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

Max. Allowed
8 8 8 8 8 8 8 8 8
Wt. (mins)

Actual

Min. Wt. Allowed

<15 <15 <15 <15 <15 <15 <15 <15 <15
(mins)

Actual

FRIABILITY TEST
Wt. of Tabs.
Corresponding
about…… mg.

Before Rotations

Allowed < 15 % < 15 % < 15 % < 15 % < 15 % < 15 < 15 % < 15 % < 15 %
%
Actual

Keseragaman Bobot

Standar 5%< bobot < 990 – 990 – 990 – 990 – 990 – 990 – 990 – 990 – 990 –
5 % (mg) 1010 1010 1010 1010 1010 1010 1010 1010 1010

Actual

Wt. of Tabs. After

100Rotations

% Loss

Pharmacist Sign.

Date
 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

CAPSUL OUTPUT FORM

Balance ID No:

Container Gross Wt (Kg) Tare Wt (Kg) Net Wt (Kg) Sign

1.

2.

3.

4.

5.

6.

7.

8.

Total Wt in Kg : No. of Capsules:

(Actual yield)

Yield

𝑊𝑒𝑖𝑔ℎ𝑡 𝑜𝑓 Capsules
= 100% x 𝑊𝑒𝑖𝑔ℎ𝑡 𝑜𝑓 𝑅𝑎𝑤 𝑀𝑎𝑡𝑒𝑟𝑖𝑎𝑙𝑠

= (Specification: 95-100%)

Finished Product Yield

𝑁𝑜.𝑜𝑓 𝐺𝑜𝑜𝑑𝑠 𝑝𝑟𝑜𝑑𝑢𝑐𝑒𝑑 𝑎𝑡 𝑡ℎ𝑒 𝑒𝑛𝑑 𝑜𝑓 𝑝𝑟𝑜𝑐𝑒𝑠𝑠+𝑅𝑒𝑗𝑒𝑐𝑡𝑠+𝑅𝑒𝑡𝑢𝑟𝑛𝑒𝑑

= 100% x 𝑁𝑜.𝑜𝑓 𝐺𝑜𝑜𝑑 𝑟𝑒𝑐𝑒𝑖𝑣𝑒𝑑 𝑎𝑡 𝑡ℎ𝑒 𝑒𝑛𝑑 𝑜𝑓 𝑝𝑟𝑜𝑐𝑒𝑠𝑠

= (Specification: 90-100%)

Standard yield: 99,00% Actual Yield:...............................Permissible yield: 98,50-99,50%

Check by Pharmacist: Date:

INSPECTION (CORE
CAPSULES)
De-dust and inspect the Capsules for black spots, foreign particles, chipped or broken Capsules. etc.
A Record the weight of rejected Capsules i.e. black spots, foreign particles, chipped or broken
Capsules and put in water for destruction.

Weight of Capsules =...Kg

B Chipped and broken Capsules of high and low weight, generated during compression, can be used
as utilizableresidue in next batches.

Transfer the inspected Capsules to double polyethylene bags inside in suitable airtight containers.
Record the weight of inspected Capsules.

Weight of Capsules =...Kg

Intimate Q.A to draw the sample of core Capsules for analysis.

 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

CAPSULE INSPECTION AND REJECTION

RECORD

Area clearance checked by: Production Pharmacist: Date:

QA Chemist: Date:

Date: Shift: Time From: To:

Previous product processed:

B. No.:

Total weight of Capsules Received for Inspection=.........kg

Inspection carried out by:

Wt of Capsules after inspection=..........Kg

Balance Used: ……….

 Sr. Gross Wt. Kg Tare Wt Kg Net Wt Kg Sr. Gross Wt. Kg Tare Wt Kg Net Wt Kg
No. No.

1. 5.

2. 6.

3. 7.

4. 8.

Total Wt.......................Kg

A) Reusable residue.......................................Kg

B) Rejects to be destroyed:..........................Kg

Pharmacist:

Date:

REJECTION & DESTRUCTION RECORD

Qty. Destroyed Method Used
Rejection generated during tablet Compression /
Inspection
Destruction Witnessed By: Production Pharmacist: Date:
Q.A. Chemist: Date:

MANUFACTURING
Date of Manufacturing:
Standard Batch Size =........Kg.
Reworking added =..........Kg.
Theoretical Yield =.........Kg.

Actual Yield =........Kg.

= …………… %
Variance =......................Kg
Pharmacist Signature:

Date:
 Page No. 37 of 16

BATCH MANUFACTURING RECORD

Product : CELEFAR B.M.R. No. BMR/001/000

B.M.R Revision 00
No./Date

Batch Size : 30.000 Capsules Ref. M.F.R. No 22 Februari 2022

Batch No. : B 22001 M.F.R. Revision 00

No & Date

To be Filled By Quality Assurance Remarks:

(Uncoated Capsules)
Appearance of the tablet:
Approved / Not Approved for Coating
Uji Keseragaman bobot...............mg.
Uji Disolusi =.............% Analyst:
Waktu Hancur =................min
Penetapan Kadar =. .µg/mL. Date:
Sudut Istirahat………..
Kompresibilitas =…….%
Kelembaban Granul = …….. %
Sifat Alir =……gram/second
Date of Manufacturing: Date of Expiry:

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
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: (FG 0333). COA No: Date:

The Disposition shall be recorded below.

Name Signature Date

Production

Quality Control

Quality Assuarance