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Sistem Kualiti


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Audit History


Sejarah Audit



  • 2016

    ·Finasteride dan Progesterone Lulus Pemeriksaan FDA Kami
    ·Progesterone Lulus Pemeriksaan EU EDQM


  • 2019

    ·Finasteride, Progesterone, dan Budesonide Lulus Pemeriksaan FDA Kami
    ·Finasteride Lulus Pemeriksaan PMDA Jepun

  • 2020

    ·Cyproterone acetate lulus Australia TGA

  • 2021

    ·Oxcarbazepine Lulus P.R. China Hubei Pemeriksaan Pentadbiran Dadah

  • 2023

    ·Oxcarbazepine dan Dutasteride Lulus Pemeriksaan MFD

  • 2024

    ·Cyproterone Acetate Lulus Pemeriksaan EDQM




Senarai Instrumen QC Utama



Instrumen Jenis Pengilang
HPLC 1100 Agilent
1200 Agilent
1260 Agilent
1290 Agilent
LC-20AT Shimadzu
LC-2030C Plus Shimadzu
Ultimate 3000 Thermofisher
Waters 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 Autopols In/ⅰS2 Rudolph
Autopol ⅳ-T Rudolph
MASTERIZER LASER Mastersizer 3000 Malvern
Helos-Rodos Sympatec
TOC OC-VWP Shimadzu
HTY-DI1500 Tain
Karl-Fisher Titrator KF870 / 831/915 Metrohm
Titrator berpotensi 905/916 Metrohm
Pengesan Endotoxin PKF-96 Acc
Penapis jet udara 200ls Hosokawa Alpine
pH meter PHS-3E Rex
Meter kekonduksian DDS-307 Rex
Suhu dan kelembapan kabinet Climacell 707 Mmm
Labonce-380gs Labonce
LHH-250SD Bluepard
CTHI-150B Hubungi



Audit History


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