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Sistem mutu


Sertifikat


Audit History


Riwayat Audit



  • 2016

    ·Finasteride lan Progesteron lulus inspeksi FDA AS
    ·Progesteron lulus pemeriksaan EDQM EU


  • 2019

    ·Finasteride, Progesteron, lan Budesonide lulus inspeksi FDA AS
    ·Finasteride lulus inspeksi PMDA Jepang

  • 2020

    ·Cyproterone acetate liwati Australia TGA

  • 2021

    ·Oxcarbazepine lulus pemeriksaan P.R. China Hubei Drug Administration

  • 2023

    ·Oxcarbazepine lan Dutasteride lulus inspeksi MFDS

  • 2024

    ·Cyproterone Acetate lulus inspeksi EDQM




Daftar Instrumen QC Utama



Instrumen Jinis Produsen
HPLC 1100 Agilent
1200 Agilent
1260 Agilent
1290 Agilent
LC-20AT Shimadzu
LC-2030C PLUS Shimadzu
Ultimate 3000 ThermoFisher
Banyu e2695 Banyu
GC 6890 Agilent
7697A Agilent
7890 Agilent
GC-2030AF Shimadzu
LAN Avatar 380/iS10 NICOLET
ALPHA-T BRUKER
UV-Vis UV-2600/2000/1800 Shimadzu
AAS AA7000 Shimadzu
Polarimeter Autopol V/ⅠS2 Rudolph
Autopol Ⅳ-T Rudolph
Laser Masterizer Kab Mastersizer 3000 Malvern
HELLO-RHODES SYMPATEC
TOC OCD-VWP Shimadzu
HTY-DI1500 TAILIN
Titrator Karl-Fisher KF870/831/915 Metrohm
Potensial Titrator 905/916 Metrohm
Detektor Endotoksin PKF-96 ACC
Air Jet Sieve 200LS Hosokawa alpine
Pengukur pH PHS-3E REX
Pengukur Konduktivitas DDS-307 REX
Kabinet Suhu lan Kelembapan Climacell 707 MMM
Labonce-380GS Labonce
LHH-250SD BLUEPARD
CTHI-150B KONTAK



Audit History


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