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Sistem kualiti


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Audit History


Sejarah Audit



  • 2016

    ·Finasteride dan Progesteron lulus pemeriksaan FDA AS
    ·Progesteron lulus pemeriksaan EDQM EU


  • 2019

    ·Finasteride, Progesteron, dan Budesonide lulus pemeriksaan FDA AS
    ·Finasteride lulus pemeriksaan PMDA Jepun

  • 2020

    ·Cyproterone acetate melepasi Australia TGA

  • 2021

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

  • 2023

    ·Oxcarbazepine dan Dutasteride lulus pemeriksaan MFDS

  • 2024

    ·Cyproterone Acetate lulus pemeriksaan EDQM




Senarai Instrumen QC Utama



Alat taip Pengeluar
HPLC 1100 Agilent
1200 Agilent
1260 Agilent
1290 Agilent
LC-20AT Shimadzu
LC-2030C PLUS Shimadzu
Ultimate 3000 ThermoFisher
Perairan e2695 Perairan
GC 6890 Agilent
7697A Agilent
7890 Agilent
GC-2030AF Shimadzu
DAN 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
Penguasa Laser Mastersizer 3000 Malvern
HELLO-RHODES SYMPATEC
TOC OCD-VWP Shimadzu
HTY-DI1500 TAILIN
Titrator Karl-Fisher KF870/831/915 Metrohm
Titrator Berpotensi 905/916 Metrohm
Pengesan Endotoksin PKF-96 ACC
Ayak Jet Udara 200LS Alpine Hosokawa
Pengukur pH PHS-3E REX
Meter Kekonduksian DDS-307 REX
Kabinet Suhu dan Kelembapan Climacell 707 MMM
Labonce-380GS Labonce
LHH-250SD BLUEPARD
CTHI-150B HUBUNGI



Audit History


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