Supervisor Produksi
Albikhair Formulasi I
Production Formulation I Supervisor
DIPERIKSA OLEH :
REVIEWED BY
NAMA JABATAN TANDA TANGAN TANGGAL
NAME POSITION SIGNATURE DATE
DISETUJUI OLEH :
APPROVED BY
NAMA JABATAN TANDA TANGAN TANGGAL
NAME POSITION SIGNATURE DATE
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.
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)
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
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
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
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
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
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
Pengujian pH
No. Tanggal pH Testing
Batch Date
1 2 3 Rata-rata CV (%)
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
7. KESIMPULAN
CONCLUSION
Proses produksi Larutan sirup x 5 %60 ml
Production of Larutan sirup x 5 %60 ml
VALID/INVALID