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Sistem kualitas


Sertifikat


Audit History


Sejarah Audit



  • 2016

    ·Finasteride dan Progesteron lulus pemeriksaan FDA AS
    ·Progesteron lulus inspeksi EDQM UE


  • 2019

    ·Finasteride, Progesteron, dan Budesonide lulus pemeriksaan FDA AS
    ·Finasteride lulus inspeksi PMDA Jepang

  • 2020

    ·Cyproterone asetat melewati TGA Australia

  • 2021

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

  • 2023

    ·Oxcarbazepine dan Dutasteride lulus pemeriksaan MFDS

  • 2024

    ·Cyproterone Acetate lulus inspeksi EDQM




Daftar Instrumen QC Utama



Instrumen Jenis Pabrikan
HPLC 1100 tangkas
1200 tangkas
1260 tangkas
1290 tangkas
LC-20AT Shimadzu
LC-2030C PLUS Shimadzu
3000 terakhir TermoFisher
Perairan e2695 perairan
hal 6890 tangkas
7697A tangkas
7890 tangkas
GC-2030AF Shimadzu
DAN Avatar 380/iS10 NIKOLET
ALPHA-T BRUKER
UV-Vis UV-2600/2000/1800 Shimadzu
AAS AA7000 Shimadzu
Polarimeter Autopol V/ⅠS2 Rudolph
Autopol Ⅳ-T Rudolph
Pengukur Laser Mastersizer 3000 Malvern
HALO-RHODES SIMPATEK
Daftar Isi OCD-VWP Shimadzu
HTY-DI1500 EKOR
Titrator Karl-Fisher KF870/831/915 Metrohm
Potensi Titrator 905/916 Metrohm
Detektor Endotoksin PKF-96 ACC
Saringan Jet Udara 200LS Pegunungan Alpen Hosokawa
pengukur pH PHS-3E REX
Pengukur Konduktivitas DDS-307 REX
Kabinet Suhu dan Kelembaban Sel Klimaks 707 MM
Labonce-380GS Labonce
LHH-250SD KETERANGAN BIRU
CTHI-150B KONTAK



Audit History


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