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PHARMA

DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132


MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 1 DARI 25
PAGE 1 OF 25

PENANDATANGANAN DI BAWAH INI MENYATAKAN BAHWA PROTOKOL


VALIDASI PROSES PENGOLAHAN LARUTAN SIRUP X 5 %(60 ml) DITERIMA
DAN TERVALIDASI
THE SIGNING BELOW STATED THAT PROCESS VALIDATION PROTOCOL OF LARUTAN SIRUP X 5 %PROCESSING
(60 ml) IS ACCEPTABLE AND VALIDATED.
DIBUAT OLEH :
ARRANGED BY
NAMA JABATAN TANDA TANGAN TANGGAL
NAME POSITION SIGNATURE DATE

Aydin Staff Pemastian Mutu


Staff Assurance Supervisor

Supervisor Produksi
Albikhair Formulasi I
Production Formulation I Supervisor

Alvin Supervisor Pemeriksaan II


Quality Control II Supervisor

DIPERIKSA OLEH :
REVIEWED BY
NAMA JABATAN TANDA TANGAN TANGGAL
NAME POSITION SIGNATURE DATE

Dhiafakhri Manajer Produksi Cair


Liquid Production Manager
Manajer Pengawasan Mutu
Aliya Quality Control Manager

DISETUJUI OLEH :
APPROVED BY
NAMA JABATAN TANDA TANGAN TANGGAL
NAME POSITION SIGNATURE DATE

Viddy Agustian R Manajer Pemastian Mutu


Quality Assurance Manager

Indri Hardini Manager Plant


Plant Manager

1. TUJUAN
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 2 DARI 25
PAGE 2 OF 25

OBJECTIVE
Protokol ini bertujuan untuk memvalidasi proses pengolahan bets dan pembuatan produk Larutan
sirup x 5 % bahwa proses pembuatan bersifat tetap dan berulang dibawah kontrol serta dapat
menyediakan produk jadi yang memenuhi seluruh aspek spesifikasi pengujian dan kualitas
This protocol intended to to validate batch processing and product manufacturing Larutan sirup x 5 % that the production is
permanent and recurring under control and can provide product that meets all aspect of the specification and quality.

2. RUANG LINGKUP
SCOPE
Validasi proses larutan sirup x 5 %cairan obat luar mencakup proses pembuatan cairan larutan
sirup x 5 %dari penimbangan hingga pencampuran.
Process validation of larutan sirup x 5 %as external liquid medicine includes process of making larutan sirup x liquid
Start from weighing up to mixingprocess.

3. PENANGGUNG JAWAB
PERSON IN CHARGE
3.1 Staff Pemastian Mutu
Quality Assurance Supervisor
Bertanggung jawab dalam pelaksanaan dan pembuatan protokol dan laporan validasi proses
Responsible for the execution and in the making of process validation protocol and report
3.2 Supervisor Pengawasan Mutu
Quality Control Supervisor
Bertanggung jawab dalam pengujian yang diperlukan.
Responsible for the required testing
3.3 Supervisor Produksi I
Production Supervisor
Bertanggung jawab dalam kebersihan dan penggunaan ruangan, peralatan dan mesin selama
proses produksi.
Responsible for the cleanliness and in the using of the rooms, equipment and machines while production process
3.4 Manager Pengawasan Mutu
Quality Control Manager
Bertanggung jawab dalam pengkajian dan pengecekan protokol dan laporan validasi proses
Responsible for reviewing and checking the process validation protocol and report.
3.5 Manager Pemastian Mutu
Quality Assurance Manager
Bertanggung jawab dalam pengkajian dan pengecekan protokol dan laporan validasi proses
Responsible for reviewing and checking the process validation protocol and report
3.6 Manager Produksi cair
Liquid Production Manager
Bertanggung jawab dalam pengkajian dan pengecekan protokol dan laporan validasi proses
Responsible for reviewing and checking the process validation protocol and report.

3.7 Manager Plant


PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 3 DARI 25
PAGE 3 OF 25

Plant Manager
Bertanggung jawab menyetujui protokol dan laporan validasi proses.
Responsible to approve protocol and report of process validation
4. REFERENSI
REFERENCE
Cara Pembuatan Obat yang Baik (CPOB) 2018

5. DEFINISI
DEFINITION
Validasi Proses adalah 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.
Process Validation is documented proof action that the process is in the limit of the parameter set can work effectively and have
repeated results to produce finished products that conform the pre-defined specification and quality attribute.

6. PROSEDUR
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 4 DARI 25
PAGE 4 OF 25

PROCEDURES
6.1 FORMULA
FORMULA
Jumlah Bets : Batch yang dievaluasi yaitu 3 batch secara berurutan
Batch Number Batches that evaluated are 3 consecutive batches
Besar Bets : 10000 botol @ 60 ml (600 L )
Batch Size 10000 bottles @ 60 ml (600 L)
Besar Kemasan : 416 Box
Packaging Size 416 Boxes
Unit Kemasan : 1 Box @ 24 botol 60 ml
Packaging Unit 1 Box @ 24 bottle (60 ml)

Bahan Jumlah Tiap Batch


Material Total per Batch
Zat x
Gliserin
Sukrosa
NaOH
KOH
Kolidon
Purified Water

6.2 SPESIFIKASI BAHAN BAKU


RAW MATERIAL SPECIFICATION
BAHAN KODE NAMA DAGANG MANUFACTURER REKANAN
Zat x
Gliserin
Sukrosa
NaOH
KOH
Kolidon
Purified Water

6.3 PERALATAN PRODUKSI


PRODUCTION EQUIPMENT
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 5 DARI 25
PAGE 5 OF 25

Merk / No. Referensi kalibrasi / kualifikasi Kalibrasi Kalibrasi


Alat
Type Inventaris KI KO KK Terakhir Selanjutnya

6.4 PERALATAN PENGUJIAN


ANALYTICAL EQUIPMENT

No. Referensi kalibrasi / kualifikasi Kalibrasi Kalibrasi


Alat Merk / Tipe Terakhir Selanjutnya
Inventaris KI KO KK
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 6 DARI 25
PAGE 6 OF 25

6.5 SISTEM PENUNJANG


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

6.6 TEKANAN, SUHU, DAN KELEMBABAN


PRESSURE, TEMPERATURE AND RELATIVE HUMIDITY
Nomer Bets :
Batch Number

Ruang Kelas Ruangan Tanggal Suhu (°C) Kelembaban (%)


Rooms Class of Rooms Date Temperature Relative Humidity/RH

Penimbangan
Weighing
Pencampuran
Mixing
Batas (Kelas E) 20-27°C Maks 70%
Limit (Class E)
MS/TMS
Kesimpulan Conformity/Non
MS/TMS
Conclusion Conformity/Non conformity
conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 7 DARI 25
PAGE 7 OF 25

Nomer Bets :
Batch Number
Ruang Kelas Ruangan Tanggal Suhu (°C) Kelembaban (%)
Rooms Class of Rooms Date Temperature Relative Humidity/RH

Penimbangan
Weighing
Pencampuran
Mixing
Batas (Kelas E) 20-27oC Max 70%
Limit (Class E)
MS/TMS
Kesimpulan Conformity/Non
MS/TMS
Conclusion Conformity/Non conformity
conformity

Nomer Bets :
Batch Number
Ruang Kelas Ruangan Tanggal Suhu (°C) Kelembaban (%)
Rooms Class of Rooms Date Temperature Relative Humidity/RH

Penimbangan
Weighing
Pencampuran
Mixing
Batas (Kelas E) 20-27oC Max 70%
Limit (Class E)
Batas (Kelas F) 20-28oC Tidak diklasifikasikan
Limit (Class F) Unclassified
MS/TMS
Kesimpulan Conformity/Non
MS/TMS
Conclusion Conformity/Non conformity
conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 8 DARI 25
PAGE 8 OF 25

6.7 BAGAN ALUR PROSES PRODUKSI


PRODUCTION FLOW CHART
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 9 DARI 25
PAGE 9 OF 25

6.8 PROSES PRODUKSI, TITIK KRITIS DAN PENGUJIAN


PRODUCTION PROCESS, CRITICAL POINT AND TESTING

Proses Bahan Alat Titik kritis Pengujian


PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 10 DARI 25
PAGE 10 OF 25

Process Materials Equipment Critical Point Testing

6.9 RENCANA PENGAMBILAN CONTOH


SAMPLING PLAN
 Tahap Proses Pencampuran (X)
Mixing process (X)
Untuk pengujian homogenitas, kadar Larutan sirup x 10%, contoh diambil dari sirkulasi
yang dilakukan pada saat proses pencampuran. Pengambilan sampel diambil setelah
sirkulasi dilakukan sebanyak 3 kali.
For Homogeneity testing, content of Larutan sirup x is 10%, samples are taken from the circulation carried out
during the mixing process. Sampling was taken after circulation and was carried out 3 times.
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 11 DARI 25
PAGE 11 OF 25

6.10 TITIK KRITIS DAN PENGUJIAN TAHAP PROSES PENIMBANGAN (I)


CRITICAL POINT, AND TESTING OF WEIGHING PROCESS (I)
Ruang : Penimbangan
Room Weighing
Alat : Timbangan
Equipment Scales
Bahan : Seluruh Bahan Baku
Material Raw materials

Batch No.
Titik Kritis
Critical point
Pengujian
Pemeriksaan Pemeriksaan
Bahan Wadah Kebersihan No. CoA
Kebenaran No. LA Bahan
No. Material Container Ruang dan Alat Bahan Baku
Penimbangan Baku
Rooms and
Weighing Checking Checking
equipments
Correctness number of raw number of raw
sanitation
material LA material CoA
1 Zat x
2 Gliserin
3 Sukrosa
4 NaOH
5
KOH
6
Kolidon
7
Purified Water
Batas Bersih Sesuai Diluluskan Diluluskan
Limit Clean Appropriate Passed Passed
MS/TMS MS/TMS MS/TMS MS/TMS
Kesimpulan
Conclusion Conformity/Non Conformity/Non Conformity/Non Conformity/Non
conformity conformity conformity conformity

Batch No.
Bahan Wadah Titik Kritis
No. Material Container Critical point
Pengujian
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 12 DARI 25
PAGE 12 OF 25

Pemeriksaan
Kebersihan No. CoA
Kebenaran Pemeriksaan No.
Ruang dan Alat Bahan Baku
Penimbangan LA Bahan Baku
Rooms and
Weighing Checking number of Checking
equipments
Correctness raw material LA number of raw
sanitation
material CoA
1 Zat x
2 Gliserin
3 Sukrosa
4 NaOH
5 Kalium
Hydrogen
Pthalat
6
Kolidon
7
Purified Water
Batas Bersih Sesuai Diluluskan Diluluskan
Limit Clean Appropriate Passed Passed
MS/TMS MS/TMS MS/TMS MS/TMS
Kesimpulan
Conclusion Conformity/Non Conformity/Non Conformity/Non Conformity/Non
conformity conformity conformity conformity

Batch No.
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 13 DARI 25
PAGE 13 OF 25

Titik Kritis
Critical point
Pengujian
Pemeriksaan Pemeriksaan
Bahan Wadah Kebersihan
Kebenaran No. LA Bahan No. CoA
No. Material Container Ruang dan Alat
Penimbangan Baku Bahan Baku
Rooms and
Weighing Checking number Checking
equipments
Correctness of raw material number of raw
sanitation
LA material CoA
1 Zat x
2 Gliserin
3 Sukrosa
4 NaOH
5 Kalium
Hydrogen
Pthalat
6
Kolidon
7
Purified Water
Batas Bersih Sesuai Diluluskan Diluluskan
Limit Clean Appropriate Passed Passed
MS/TMS MS/TMS MS/TMS MS/TMS
Kesimpulan
Conclusion Conformity/Non Conformity/Non Conformity/Non Conformity/Non
conformity conformity conformity conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 14 DARI 25
PAGE 14 OF 25

6.11 TITIK KRITIS DAN PENGUJIAN TAHAP PROSES PENAMBAHAN AIR KE


DALAM TANGKI (II)
CRITICAL POINT AND TESTING THE STAGE OF WATER ADDITION PROCESS INTO THE TANK (II)
Ruang : Proses Pencampuran
Room Mixing Process
Alat : Mixer Pencampur
Equipment Mixer
Bahan : Purified Water
Materials Purified Water

Tanggal Pengujian pH
No. Batch Date pH Testing

Batas
5-7
Limit
Kesimpulan MS/TMS
Conclusion Conformity/Non conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 15 DARI 25
PAGE 15 OF 25

6.12 TITIK KRITIS DAN PENGUJIAN TAHAP PROSES PENCAMPURAN NaOH


DAN PURIFIED WATER (III)
CRITICAL POINT AND TESTING OF THE MIXING PROCESS OF NaOH AND PURIFIED WATER (II)
Ruang : Proses Pencampuran
Room Mixing Process
Alat : Mixer Pencampur
Equipment Mixer
Bahan : NaOH dan Purified Water
Material NaOH and Purified Water

Pengujian
Tanggal Testing
No Batch
Date
pH

Batas 11,5-13,00
Limit
Kesimpulan MS/TMS
Conclusion Conformity/Non conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 16 DARI 25
PAGE 16 OF 25

6.13 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN A (IV)


CRITICAL POINT AND TESTING OF A MIXING PROCESS (IV)
Ruang : Proses Pencampuran
Room Mixing Process
Alat : Mixer Pencampur
Equipment Mixer
Bahan : Hasil pencampuran NaOH (III), Purified Water
Materials NaOH mixture, Purified Water

Titik Kritis Pengujian


Critical point Testing
Tanggal
No. No. Batch Waktu Kecepatan
Date Visual
Mixing Mixing Visual
Mixing time Mixing speed
1
2
3
Batas Jernih
6 menit 14 Hz
Limit Clear

Kesimpulan MS/TMS MS/TMS MS/TMS


Conclusion Conformity/Non Conformity/Non
Conformity/Non conformit
conformit conformit
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 17 DARI 25
PAGE 17 OF 25

6.14 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN KOLLIDON 30 DAN


PURIFIED WATER (V)
CRITICAL POINT AND TESTING OF KOLLIDON 30 AND PURIFIED WATER MIXING PROCESS (V)
Ruang : Proses pencampuran
Room Mixing Process
Alat : Mixer Pencampur
Equipment Mixer
Bahan : Kollidon 30, Purified Water
Materials Kollidon 30 and Purified Water

Pengujian
Tanggal Testing
No. No. Batch
Date Visual
Visual
1
2
3
Batas Terlarut Berwarna Kuning
Limit Dissolved, yellow

Kesimpulan MS/TMS
Conclusion Conformity/Non conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 18 DARI 25
PAGE 18 OF 25

6.15 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN B (VI)


CRITICAL POINT AND TESTING OF B MIXING PROCESS (VI)
Ruang : Proses pencampuran
Room Mixing Process
Alat : Mixer Pencampur
Equipment Mixer
Bahan : Hasil pencampuran A (IV), Hasil pencampuran Kollidon 30 (V)
Materials Risult of Mixture A(IV), Risult of Kollidon 30 mixture

Titik Kritis Pengujian


No Tanggal Critical Point Testing
No. Batch
. Date Waktu Kecepatan Visual
Time Speed Visual
1
2
3
Batas Jernih Terlarut
Limit
5 menit 14 Hz
Clear, dissolved

Kesimpulan MS/TMS MS/TMS MS/TMS


Conformity/Non Conformity/Non Conformity/Non
Conclusion
conformity conformity conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 19 DARI 25
PAGE 19 OF 25

6.16 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN C (VII)


CRITICAL POINT AND TESTING OF C MIXING PROCESS (VII)
Ruang : Proses Pencampuran
Room Mixing Process
Alat : Mixer pencampur
Equipment Mixer
Bahan : Zat x, Hasil Pencampuran B (VI)
Material Zat x, Risult of B mixture (VI)

Titik Kritis Pengujian


Critical Point Testing
Tanggal
No. No. Batch Waktu Kecepatan Waktu
Date
Sirkulasi Mixer Mixing Visual
Circulation Time Mixer Speed Mixing Time
1
2
3
Merah
Batas 40 menit 19 Hz 40 menit kecoklatan
Limit
Terlarut
Kesimpulan MS/TMS MS/TMS MS/TMS MS/TMS
Conformity/Non Conformity/No Conformity/Non Conformity/Non
Conclusion
conformity n conformity conformity conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 20 DARI 25
PAGE 20 OF 25

6.17 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN GLISERIN DAN


SUKROSA (VIII)
CRITICAL POINT AND TESTING A GLISERIN AND SUKROSA MIXING PROCESS (VIII)

Ruang : Proses Pencampuran


Room Mixing Process
Alat : Mixer Pencampur
Equipment Mixer
Bahan : Gliserin, Sukrosa
Material Gliserin and Sukrosa

Pengujian
Tanggal
No. No. Batch Testing
Date
Visual
1
2
3
Batas Terlarut
Limit Soluble
Kesimpulan MS/TMS
Conclusion Conformity/Non conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 21 DARI 25
PAGE 21 OF 25

6.18 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN D (IX)


CRITICAL POINT AND TESTING Of D MIXING PROCESS (VIII)

Ruang : Proses Pencampuran


Room Mixing Process
Alat : Mixer pencampur
Equipment Mixer
Bahan : Hasil Pencampuran Glycerolum+Sukrosa (VIII), Hasil Pencampuran C (VII)

Material Risult of Gliserin and Sukrosa mixture, Risult of C mixture

Titik Kritis Pengujian


Critical Point Testing
Tanggal
No. No. Batch Kecepatan Waktu Waktu
Date
Mixer Mixing Sirkulasi Visual
Mixer Speed Mixing Time Circulation Time
1
2
3
Merah Kecoklatan
Batas Terlarut
Limit
19 Hz 4 menit 4 menit
Brownish red
Soluble

Kesimpulan MS/TMS MS/TMS MS/TMS MS/TMS


Conformity/Non Conformity/Non Conformity/Non
Conclusion Conformity/Non conformity
conformity conformity conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 22 DARI 25
PAGE 22 OF 25

6.19 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN E (X)


CRITICAL POINT AND TESTING OF E MIXING PROCESS (IX)
Ruang : Proses Pencampuran
Room Mixing Process
Alat : Mixer Pencampur
Equipment Mixer
Bahan : Hasil Pencampuran D (IX), Larutan NaOH
Material Risult of D mixture (IX), NaOH solution

Titik Kritis Pengujian


Critical Point Testing
No. Tanggal
No. Kecepatan Waktu Waktu
Batch Date
Mixer Mixing Sirkulasi Visual
Mixer Speed Mixing Time Circulation Time
1
2
3
Merah
Batas 19 Hz 10 menit 10 menit Kecoklatan
Limit
Brownish red

Kesimpulan MS/TMS MS/TMS MS/TMS MS/TMS


Conformity/Non Conformity/Non Conformity/Non Conformity/Non
Conclusion
conformity conformity conformity conformity

Pengujian pH
No. Tanggal pH Testing
Batch Date
1 2 3 Rata-rata CV (%)

Batas Max. 2,00%


Limit
Kesimpulan MS/TMS
Conclusion Conformity/Non conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 23 DARI 25
PAGE 23 OF 25

6.20 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN F (XI)


CRITICAL POINT AND TESTING PROCESS OF F MIXTURE (XI)
Ruang : Proses Pencampuran
Room Mixing Process
Alat : Mixer Pencampur
Equipment Mixer
Bahan : Hasil Pencampuran E (IX), Larutan NaOH
Material Risult of E mixture (IX), NaOH solution

Pengujian No Batch
Testing Batas
Tanggal Limit
Date

Kadar (%)
Concentration (%)
85-120%
Rata-rata
Average
CV(%) Max 2,00%
Kesimpulan MS/TMS
Conclusion Conformity/Non conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 24 DARI 25
PAGE 24 OF 25

6.21 TITIK KRITIS DAN PENGUJIAN TAHAP PENCAMPURAN G (XIII)


Critical Point and testing of G mixture (XIII)
Ruang : Proses Pencampuran
Room Mixing Process
Alat : Mixer pencampur
Equipment Mixer
Bahan : Hasil Pencampuran F (XI), Hasil Pembuatan Buffer (XII)
Material Risult of F mixture (XI), risult of buffer (XII)

Titik Kritis Pengujian


Critical Point Testing
Tanggal
No. No. Batch Waktu Kecepatan Waktu
Date
Mixing Mixing Sirkulasi Visual
Mixing Time Mixing Speed Circulation Time
1
2
3
Batas Merah Kecoklatan
3 menit 19 Hz 3 menit
Limit Brownish red

Kesimpulan MS/TMS MS/TMS MS/TMS MS/TMS


Conformity/Non Conformity/Non Conformity/Non
Conclusion Conformity/Non conformity
conformity conformity conformity
PHARMA
DOKUMEN SISTEM MANAJEMEN KODE DOK : DSM-VP09191132
MANAGEMENT SYSTEM DOCUMENT DOCUMENT CODE
TGL. REVISI : 11 AGUSTUS 2019
PROTOKOL VALIDASI PROSES REVISION DATE
PENGOLAHAN LARUTAN SIRUP X 5 % TGL. BERLAKU
: 1 SEPTEMBER 2019
(60 ml) EFFICIENT DATE
PROTOCOL VALIDATION REPORT OF EDISI/REVISI
LARUTAN SIRUP X PROCESSING 10% (60 ml) EDITION/REVISION : 1/1
HALAMAN 25 DARI 25
PAGE 25 OF 25

6.22 LAPORAN PENYIMPANGAN


DEVIATION REPORT
6.15.1 Penyimpangan :-
6.15.2 Penyesuaian yang dilakukan :-
6.15.3 Dampak :-

7. KESIMPULAN
CONCLUSION
Proses produksi Larutan sirup x 5 %60 ml
Production of Larutan sirup x 5 %60 ml
VALID/INVALID

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