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Sistem mutu


Sertifikat



Riwayat Audit



  • 2016

    ·Finasteride lan Progesteron lulus inspeksi US Food and Drug Administration
    ·Progesteron lulus inspeksi Kantor Pendaftaran Polandia EU
    ·Asam folinat lulus P. R. China Hubei Food and Drug Administration inspection

  • 2017

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

  • 2018

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

  • 2019

    ·Finasteride, Progesteron, lan Budesonide lulus inspeksi US Food and Drug Administration
    ·Finasteride lulus inspeksi Badan Farmasi lan Alat Medis Jepang

  • 2020

    ·Cyproterone acetate lulus Administrasi Barang Terapi Australia

  • 2021

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




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
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
Laser Masterizer Kab Mastersizer 3000 Malvern
HELOS-RODOS SYMPATEC
TOC TOC-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 STIK




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