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Sistem kualiti


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Sejarah Audit



  • 2016

    ·Finasteride dan Progesteron lulus pemeriksaan Pentadbiran Makanan dan Dadah AS
    ·Progesteron lulus pemeriksaan Pejabat Pendaftaran Poland EU
    ·Asid folinik lulus pemeriksaan P. R. China Hubei Food and Drug Administration

  • 2017

    ·Finasteride, Progesteron, Budesonide dan Gestodene) lulus pemeriksaan P. R. China Hubei Food and Drug Administration

  • 2018

    ·Mifepristone, Anorethindrane dipropionate dan Cyproterone acetate lulus P. R. China Hubei Food and Drug Administration inspection
    ·Oxcarbazepine dan Ganciclovir lulus pemeriksaan P. R. China Hubei Food and Drug Administration

  • 2019

    ·Finasteride, Progesteron, dan Budesonide lulus pemeriksaan Pentadbiran Makanan dan Ubat-ubatan AS
    ·Finasteride lulus pemeriksaan Agensi Farmaseutikal dan Perubatan Jepun

  • 2020

    ·Cyproterone acetate lulus Pentadbiran Barangan Terapeutik Australia

  • 2021

    ·Oxcarbazepine lulus pemeriksaan P.R. China Hubei Drug Administration
    ·Medroxyprogesterone Acetate, Estradiol, Tibolone dan Methylprednisolone lulus pemeriksaan P. R. China Hubei Drug Administration




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
IR Avatar 380/iS10 NICOLET
ALPHA-T BRUKER
UV-Vis UV-2600/2000/1800 Shimadzu
AAS AA7000 Shimadzu
Polarimeter Autopol V/â S2 Rudolph
Autopol â£-T Rudolph
Penguasa Laser Mastersizer 3000 Malvern
HELOS-RODOS SYMPATEC
TOC TOC-VWP Shimadzu
HTY-DI1500 TAILIN
Titrator Karl-Fisher KF870/831/915 Metrohm
Titrator Berpotensi 905/916 Metrohm
Pengesan Endotoksin PKF-96 ACC
Penapis 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 STIK




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