Catatan Pengolahan Batch Page 1 of 18

Batch Processing Notes

Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

Penandatanganan Dibawah Ini Menyatakan Bahwa Laporan Validasi Proses Pengolahan

Krim Mikonazole Nitrate 5% Diterima Dan Tervalidasi
The Signing Below Stated That Process Validation Report of Miconazole Nitrate Cream 5% is
Acceptable and Validated

Dibuat Oleh :
Created by
Nama Jabatan Tanda Tanggal
Name Position Tangan Date
Signature
Siti Nur Azizah Staff Pemastian Mutu Staff
Assurance Supervisor
Febby Andriani Supervisor Produksi
Production Supervisor
Moh. Nizar Ariful Supervisor Pemeriksaan II
Haq Quality Control II Supervisor

Diperiksa Oleh :
Checked by
Nama Jabatan Tanda Tanggal
Name Position Tangan Date
Signature
Maria Magdalena S Manajer Produksi Solid
Solid Production Manager
Fatimah S.Hi La Manajer Pengawasan Mutu
Hasan Quality Control Manager

Disetujui Oleh :
Approved by
Nama Jabatan Tanda Tanggal
Name Position Tangan Date
Signature
Viddy Agustian R Manajer Pemastian Mutu
Quality Assurance Manager
Dian Nugra Manager Plant
Plant Manager

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 2 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

1. Tujuan (Objective)
1.1. Untuk memvalidasikan dan mendokumentasikan bahwa proses pengolahan bets dan
proses manufaktur krim mikonazole nitrate 5% secara konsisten menghasilkan produk
yang memenuhi kriteria dan karakteristik kualitas.
To validate and document that the batch processing and manufacturing process of
ranitidin miconazole nitrate cream 5% consistently manufactures products that conform
to quality criteria and quality characteristics.

2. Ruang Lingkup (Scope)

2.1. Validasi proses berlaku untuk produk krim mikonazole nitrate 5% Penta Pharmaceutical
Company
Process validation applies to miconazole nitrate cream 5% Penta Pharmaceutical
Company product
2.2. Validasi proses mencakup proses pembuatan krim mikonazole nitrate 5% dari
penimbangan hingga pencampuran
Process validation shall be manufacturing process of miconazole nitrate cream 5% start
from weighing up to mixing process

3. Tanggung Jawab (Responsibility)

3.1. Staff Pemastian Mutu bertanggung jawab menuliskan rencana validasi proses dan
laporan validasi proses dan mendukung aktivitas tim validasi proses.
The Quality Assurance staff is responsible for writing the process validation plan and the
procwss validation report and supporting the process validarion team activities.
3.2. Supervisor Pengawasan Mutu bertanggung jawab dalam pengujian yang diperlukan
Quality Control Supervisor responsible for the required testing
3.3. Supervisor Produksi bertanggung jawab dalam kebersihan dan penggunaan ruangan,
peralatan dan mesin selama proses produksi.
Production supervisor responsible for the cleanliness and in the using of the rooms,
equipment and machine while production process
3.4. Manager Pengawasan Mutu, Manager Pemastian Mutu dan Manager Produksi Solid
bertanggung jawab pada staff bagian validasi proses dan tim validasi proses,
pengecekan protokol dan laporan validasi proses.

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 3 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

The Quality Control, Quality Assurance and Solid Production Manager shall be
responsible for the process validation and the process validation team, checking the
process validation protocol and report
3.5. Manager Plant bertanggung jawab mengonfirmasi dan menyetujui rencana, jadwal,
protocol dan laporan validasi proses
Plant Manager responsible to confirm and approve the related plans, schedule,
checking the process validation protocol and report

4. Isi (Content)
4.1. Definisi Validasi Proses
Definition of process validation
Tindakan pembuktian yang didokumentasikan bahwa proses yang dilakukan dalam
batas parameter yang ditetapkan dapat bekerja secara efektif dan memberi hasil yang
dapat terulang untuk menghasilkan produk jadi yang memenuhi spesifikasi dan atribut
mutu yang ditetapkan sebelumnya.
Proof of action documented that the process carried out within established parameters
can work effectively and produce repeatable results to produce finished products that
meet the specifications and quality attributes previously specified

4.2. Ketentuan
4.2.1. Sebelum penjualan produk, validitas parameter (bahan baku, kondisi operasional,
dll) yang mempengaruhi kualitas harus memenuhi kriteria material pre-existing.
Before the sale of the drug substance, the validity of the parameters (raw material
properties, operating conditions, etc.) affecting the quality should be met based on
pre-existing material criteria.
4.2.2. Dilakukan dan dianalisa tiga bets berturut-turut proses produksi dengan volume
produksi sesuai penjualan, dan dilakukan evaluasi menyeluruh. Pada kasus
tersebut, ketiga bets manufaktur harus memenuhi spesifikasi.
Conduct and analyze the three consecutive production batch of the production
volume produced for sale, and perform the overall evaluation. In this case, all
three manufacturing batch shall meet specification. .

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 4 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

5. Prosedur
5.1. Formula (Formula)
Jumlah bets : Bets yang akan dievaluasi yaitu 3 bets secara berurutan
Batch Number : Batches that evaluated are 3 batches
Besar bets : 100305 tube @ 10 gram (1003.05 kg)
Batch Size : 100305 tube @ 10 gram (1003.05 kg)
Besar Kemasan : 4012 box kecil @ 25 tube
Packaging Size : 4012 small boxes @ 25 tube
Unit kemasan : 401 box besar @ 10 box kecil
Packaging Unit : 401 large box @ 10 small boxes

Bahan Jumlah Tiap Batch (Kg)

Material Total Perbatch
Mikonazole Nitrat (5%) 21.00
Tefose 63 200.00
Labrafil Ma 30.00
Mineral oil (Parafin liquid) 30.00
Hidroksianisol Butilat 0.05
Asam Benzoat 2.00
Aquadest 720.00

5.2. Spesifikasi Bahan Baku (Raw Material Specification)

BAHAN KODE NAMA DAGANG MANUFACTURER
Mikonazole Nitrat (5%)
Tefose 63
Labrafil Ma
Mineral oil (Parafin liquid)
Hidroksianisol Butilat
Asam Benzoat
Aquadest

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 5 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

5.3. Peralatan Produksi (Production Equipment)

ALAT MEREK NO. REFRENSI KALIBR KALIBR
INVENTA KALIBRASI/KUALIFIKASI ASI ASI
RIS KI KO KK TERAKH LANJUT
IR AN
Timbangan
250 gram ± 10
mg
Timbangan
500 kg ± 10
gram
Mesin
Pencampur
Fase Minyak
(Oil Tank)
Mesin
Pencampur
Fase Air
(Water Tank)
Mesin
Pencampur
Fase Minyak
dan Air
(Main Tank)
Homogenizer

5.4. Peralatan Pengujian (Analytical Equipment)

REFRENSI KALIBR KALIBR
NO.
KALIBRASI/KUALIFIKAS ASI ASI
ALAT MEREK INVENTA
I TERAKH LANJUT
RIS
KI KO KK IR AN
Metilen Blue
Mikroskop
Optik
Viscometer

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 6 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

Brookfield
pH meter
KCKT
Object Glass
Timbangan
gram
Plat Tekan

5.5. Sistem Penunjang (Utility System)

Sarana Penunjang Referensi KI Referensi KO Referensi KK
Utilities IQ References OQ References PQ References

5.6. Tekanan, Suhu, dan Kelembaban (Pressure, Temperature and Relative Humidity)
Nomer Bets (Batch Number): M32001R
Ruang Kelas Tanggal Suhu (oC) Kelembapan
Rooms Ruangan Date Temperature Relative Humidity
Class of
Rooms
Penimbangan
Peleburan
Pelarutan
Pencampuran
Batas (Kelas E) 20-27°C Maks 70%
Kesimpulan MS/TMS MS/TMS
Conformity/No Conformity/Non
n conformity conformity

Nomer Bets (Batch Number): M32002R

Ruang Kelas Tanggal Suhu (oC) Kelembapan
Rooms Ruangan Date Temperature Relative Humidity
Class of

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 7 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

Rooms
Penimbangan
Peleburan
Pelarutan
Pencampuran
Batas (Kelas E) 20-27°C Maks 70%
Kesimpulan MS/TMS MS/TMS
Conformity/No Conformity/Non
n conformity conformity

Nomer Bets (Batch Number): M32003R

Ruang Kelas Tanggal Suhu (oC) Kelembapan
Rooms Ruangan Date Temperature Relative Humidity
Class of
Rooms
Penimbangan
Peleburan
Pelarutan
Pencampuran
Batas (Kelas E) 20-27°C Maks 70%
Kesimpulan MS/TMS MS/TMS
Conformity/No Conformity/Non
n conformity conformity

5.7. Bagan Alur Proses Produksi (Production Flow Chart)

Penimbangan bahan baku

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 8 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

Peleburan fase minyak pada suhu 65-70°C Pemanasan air pada suhu 80-90°C di Main
di Oil Tank (Tefose 63, Labrafil M, Mineral tank
oil

Dispersikan mikonazol dan BHA dengan Larutkan asam benzoat pada suhu 65-70°C
kecepatan tinggi selama 20 menit

Pencampuran fase minyak dan

air di main tank dengan
IPC:
homogenization Pemerian
pH
Stabilitas krim
Karantina produk antara

IPC :
-Pemerian -Bobot rata-rata
-Indentifikasi -pH
-Kadar zat berkhasiat Pengisian ke tube
-Homogenitas
-Stabilitas

Karantina produk ruahan

IPC :
-Pemerian -pH
Pengemasan -Indentifikasi
-Kadar zat berkhasiat
-Homogenitas
Karantina produk jadi -Koefesien variasi

Gudang obat jadi

5.8. Proses Produksi, Titik Kritis, dan Pengujian (Production process, Critical Point and
Testing)
Bahan Proses Produksi Peralatan Parameter Kritis Parameter

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 9 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

pengujian
Seluruh Bahan Penimbangan I Timbangan ₋ Kebersihan Pemeriksaan
Baku ruangan dan Bahan Baku
peralatan Berdasarkan
₋ Pemeriksaan Nomer bets,
kebenaran No.Lot dan CoA
penimbangan
₋ Tefose 63 Peleburan II Oil tank Pencatatan suhu ₋ Homogenitas
₋ Labrafil M fase minyak pemanasan (visual) bahan
₋ Mineral oil fase minyak
₋ suhu fase minyak
Proses (II) + Dispersi III Oil tank - Waktu - Homogenitas
Mikonazole nitrat bahan obat - Kecepatan (visual)
dan BHA dan eksipien pencampuran
ke fase
minyak
Aquades Pemanasan IV Main tank - Suhu pemanasan - Suhu aquades
aquades - Kecepatan
Pengadukan
Proses IV + Asam Pelarutan V Main tank - Kecepatan - Suhu fase air
benzoat asam benzoat Pengadukan - Homogenitas
- Suhu untuk (visual)
melarukan
Proses III + Proses Pencampuran VI Main tank - Suhu - Suhu campuran
V fase minyak - Kecepatan - Homogenitas
dan air pengadukan (visual)
- pH
- Pemerian
- Kadar mikonazol
- Viskositas

5.9. Titik Kritis dan Pengujian Pada Proses Penimbangan

(Critical Point, and testing of weighing process)
Ruang : Penimbangan
Room Wheighing
Alat : Timbangan
Equipment Scales

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 10 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

Bahan : Seluruh Bahan Baku

Material Raw materials

Batch No : M32001R
Titik Kritis Pengujian
Critical point
Kebersiha Kebenaran Pemeriksaa Pemeriksaan
Bahan Wadah n Ruang Penimbang n LA. CoA. Bahan
No.
Material Container dan Alat an Bahan Baku Baku
Rooms and Weighing Checking of Checking of
equipment Correctness raw material raw material
sanitation LA CoA
1 Mikonazole Nitrat
(5%)
2 Tefose 63
3 Labrafil Ma
4 Mineral oil (Parafin
liquid)
5 Hidroksianisol
Butilat
6 Asam Benzoat
Batas Bersih Ssesuai Diluluskan Diluluskan
Limit Clean Appropiate Passed Passed
Kesimpulan MS/TM MS/TMS MS/TMS MS/TMS
Conclusion S Conformi Conform Conformity/
Confor ty/Non ity/Non Non
mity/No conformit conformi conformity
n y ty
conform
ity

Batch No : M32002R

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 11 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

Titik Kritis Pengujian

Critical point
Kebersiha Kebenaran Pemeriksaa Pemeriksaan
Bahan Wadah n Ruang Penimbang n LA. CoA. Bahan
No.
Material Container dan Alat an Bahan Baku Baku
Rooms and Weighing Checking of Checking of
equipment Correctness raw material raw material
sanitation LA CoA
1 Mikonazole Nitrat
(5%)
2 Tefose 63
3 Labrafil Ma
4 Mineral oil (Parafin
liquid)
5 Hidroksianisol
Butilat
6 Asam Benzoat
Batas Bersih Ssesuai Diluluskan Diluluskan
Limit Clean Appropiate Passed Passed
Kesimpulan MS/TM MS/TMS MS/TMS MS/TMS
Conclusion S Conformi Conform Conformity/
Confor ty/Non ity/Non Non
mity/No conformit conformi conformity
n y ty
conform
ity

Batch No : M32003R
Titik Kritis Pengujian
Critical point
Kebersiha Kebenaran Pemeriksaa Pemeriksaan
N Bahan Wadah n Ruang Penimbang n LA. CoA. Bahan
o. Material Container dan Alat an Bahan Baku Baku
Rooms and Weighing Checking of Checking of
equipment Correctness raw material raw material
sanitation LA CoA
1 Mikonazole Nitrat

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 12 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

(5%)
2 Tefose 63
3 Labrafil Ma
4 Mineral oil (Parafin
liquid)
5 Hidroksianisol Butilat
6 Asam Benzoat
Batas Bersih Ssesuai Diluluskan Diluluskan
Limit Clean Appropiate Passed Passed
Kesimpulan MS/TM MS/TMS MS/TMS MS/TMS
Conclusion S Conformi Conform Conformity/
Confor ty/Non ity/Non Non
mity/No conformit conformi conformity
n y ty
conform
ity

5.10. Titik Kritis Dan Pengujian Dalam Tahap Peleburan Fase Minyak
Critical Point and Testing on the Melting Oil Phase Proccess
Ruang : Ruang pencampuran
Room Mixing Process
Alat : Oil tank
Equipment
Bahan :Tefose 63, Labrafil M, Mineral oil (Parafin oil)
Material

No No. Tanggal Titik Kritis Pengujian

Batch
Suhu Suhu Fase Minyak Homogenitas
Peleburan
1 M32001R
2 M32002R
3 M32003R
Batas 65-70°C 65-70°C Homogen/jernih
Limit
Kesimpulan MS/TMS MS/TMS MS/TMS
Conclusion Conformity/No Conformity/Non Conformity/No

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 13 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

n conformity conformity n conformity

5.11 Titik Kritis dan Pengujian Dalam Tahap Dispersi Mikonazole dan BHA
Critical Point and Testing on the Dipersion of Miconazole and BHA Proccess
Ruang : Ruang Pencampuran
Room Mixing Process
Alat : Oil tank
Equipment
Bahan : Tefose 63, Labrafil M, Mineral oil (Parafin oil) + Mikonazol + BHA
Material

No No. Tanggal Titik Kritis Pengujian

Batch
Kecepatan Waktu Homogenitas
Pengadukan pengadukan
1 M32001R
2 M32002R
3 M32003R
Batas Kecepatan tinggi 20 menit Homogen / jernih
Limit
Kesimpulan MS/TMS MS/TMS MS/TMS
Conclusion Conformity/Non Conformity/No Conformity/Non
conformity n conformity conformity

5.12 Titik Kritis dan Pengujian Dalam Tahap Pemanasan aquades

Critical Point and Testing on the heated of aquadest Proccess
Ruang : Ruang Pencampuran
Room Mixing process
Alat : Main tank
Equipment
Bahan : Aquades
Material
Titik Kritis Pengujian
No No. Batch Tanggal
Suhu Pemanasan Suhu Pemanasan
1 M32001R
2 M32002R

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 14 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

3 M32003R
Batas 80-90°C 80-90°C
Limit
Kesimpulan MS/TMS MS/TMS
Conclusion Conformity/Non Conformity/Non
conformity conformity

5.13. Titik Kritis dan Pengujian Dalam Tahap Pelarutan Asam benzoat
Critical Point and testing on the Dissolve Benzoic Acid Proccess
Ruang/room : Ruang Pencampuran/ Mixing Proccess
Alat : Main Tank
Equipment
Bahan : Aquades + Asam benzoat

Titik Kritis Pengujian

N No.
Tanggal Kecepatan Suhu Homogenitas Suhu Fase air
o. Batch
Pengadukan Pelarutan
M32001
1
R
M32002
2
R
M32003
3
R
Batas Homogen / 65-70°C
65-70°C
Limit Jernih
MS/TMS MS/TMS MS/TMS
Kesimpulan
Conformity/N Conformity/N Conformity/Non
Conclusion
on conformity on conformity conformity

5.14. Titik Kritis Dalam Tahap Pencampuran Fase Air dan Fase Minyak
Critical Point on the Mixing Water Phase and Oil Phase Proccess
Ruang : Ruang Pencampuran
Room Mixing Proccess
Alat : Main Tank
Equipment

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 15 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

Bahan : Fase Air (aquades + asam benzoat) dan Fase Minyak ( Tefose 63 + Labrafil M +
Mineral Material oil/ parafin oil + BHA + Mikonazol )

Titik Kritis
No. No. Batch Tanggal Kecepatan
Suhu Pencampuran
Pengadukan
1 M32001R
2 M32002R
3 M32003R
Batas
65-70°C
Limit
MS/TMS MS/TMS
Kesimpulan
Conformity/Non Conformity/Non
Conclusion
conformity conformity

Pengujian
Pengujian
Tangga Suhu pH Homogenit Kadar Viskositas
No. No. Batch Pemeria
l Pencamp as Zat Aktif
n
uran
1 M32001R
2 M32002R
3 M32003R
Batas Homogen 90-110%
Putih 65-70°C
Limit
MS/T MS/TM MS/TM MS/TMS MS/TM MS/TM
MS S S Conformity S S
Kesimpulan Conform Conformit Conformit /Non Conformit Conformit
Conclusion ity/Non y/Non y/Non conformity y/Non y/Non
conform conformit conformit conformit conformit
ity y y y y

6. Pola Pengambilan Sampel

Pengambilan sampel pada proses pencampuran
Untuk mengetahui homogenitas dari krim dapat dilakukan dengan menimbang 1 gram krim
yang diambil setelah proses pencampuran, kemudian diletakkan diatas objek glass dan
ditutup dengan objek glass yang lain. Diamati apakah terdapat gumpalan, jika tidak maka
sampel dapat dinyatakan homogen.

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 16 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

7. Dokumentasi
Seluruh langkah dalam proses pengolahan didokumentasikan dalam Catatan Pengolahan Bets.
Langkah-langkah lain dicakup dalam dokumen di bawah ini :

No. Judul Dokumen No. Dokumen Tanggal

urut Berlaku

Keluar Masuk Ruang Produksi

Kalibrasi

Kualifikasi Peralatan

Penanganan Logbook

Pengoperasian Timbangan Merek …… Tipe…..

Pengoperasian Oil Tank Merek …… Tipe …..

Pengoperasian water Tank Merek …… Tipe

…..

Pengoperasian Main tank Merek ……Tipe …..

Pembersihan Timbangan Merek …… Tipe …..

Pembersihan Oil Tank Merek …… Tipe …..

Pembersihan water Tank Merek …… Tipe …..

Pembersihan Main tank Merek ……

Tipe …..

Cara Menimbang yang Benar

Pengawasan selama proses

Pemeriksaan Produk Jadi

Pembersihan Peralatan Laboratorium

Pembersihan Ruangan Laboratorium

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 17 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

Pembersihan Ruang Timbang

Pembersihan Ruang Pencampuran

Pembersihan Ruang Pengisian

Validasi Pembersihan Peralatan

Validasi Pembersihan Ruangan

Validasi Metode Pemeriksaan

8. Pengemasan
Bets validasi akan dikemas dalam botol wadah yang inert dan tidak transparan

9. Stabilitas
Pada bets validasi akan dilakukan uji stabilitas untuk melanjutkan Uji Stabilitas yang telah
dilakukan sebelumnya. Untuk melakukan Uji Stabilitas diperlukan Protokol terpisah.

10. Penggunaan Bets

Bets validasi dapat disetujui untuk dipasarkan apabila memenuhi persyaratan spesifikasi.

11. Laporan Penyimpangan

DEVIATION REPORT
Penyimpangan :-
Penyesuaian yang dilakukan :-
Dampak :-
12. Kesimpulan
Conclusion
Proses produksi krim mikonazole nitrat 5%
Production of Miconazole Nitrate cream 5%
VALID/INVALID
13. Dokumen Rujukan

BPN–QAS-0401PVR
 Catatan Pengolahan Batch Page 18 of 18
Batch Processing Notes
Laporan Validasi Proses Pengolahan Krim Mikonazole Nitrat 5% Document number :
BPN–QAS-0101PVR
(Process Validation Report Processing Of Miconazole Nitrate
Cream 5%)
Created by : Checked by : Approved by: Revision :
Department : 0
Quality Assurance Apply date :
Review the document : Siti Nur Azizah Fatimah S Hi La Hasan Dian Nugra 11 April 2020

BPOM. 2009. Pedoman Cara Pembuatan Bahan Baku Aktif Obat yang Baik.

BPOM. 2013. Petunjuk Operasional Penerapan Pedoman Cara pembuatan Obat yang Baik 2012.

Raymond Rowe C., Paul Sheskey J. , Marian E quinn. 2009. Handbook of pharmaceutical
exipient sixth edition.

Farmakope indonesia edisi 5.

BPN–QAS-0401PVR