Bahay > Mga Pangunahing Kakayahan > Sistema ng kalidad

Sistema ng kalidad


Mga sertipiko


Audit History


Kasaysayan ng Audit



  • 2016

    ·Ang Finasteride at Progesterone ay pumasa sa inspeksyon ng US FDA
    ·Ang progesterone ay pumasa sa EU EDQM inspeksyon


  • 2019

    ·Ang Finasteride, Progesterone, at Budesonide ay pumasa sa inspeksyon ng US FDA
    ·Ang Finasteride ay pumasa sa Japan PMDA inspection

  • 2020

    ·Ang Cyproterone acetate ay pumasa sa Australia TGA

  • 2021

    ·Ang Oxcarbazepine ay pumasa sa inspeksyon ng P.R. China Hubei Drug Administration

  • 2023

    ·Ang Oxcarbazepine at Dutasteride ay pumasa sa inspeksyon ng MFDS

  • 2024

    ·Ang Cyproterone Acetate ay pumasa sa inspeksyon ng EDQM




Pangunahing QC Instruments Listahan



Instrumento Uri Manufacturer
HPLC 1100 Agilent
1200 Agilent
1260 Agilent
1290 Agilent
LC-20AT Shimadzu
LC-2030C PLUS Shimadzu
Ultimate 3000 ThermoFisher
Tubig e2695 Tubig
GC 6890 Agilent
7697A Agilent
7890 Agilent
GC-2030AF Shimadzu
AT 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
Laser Mastersizer Mastersizer 3000 Malvern
HELLO-RHODES SYMPATEC
TOC OCD-VWP Shimadzu
HTY-DI1500 TAILIN
Karl-Fisher Titrator KF870/831/915 Metrohm
Potensyal na Titrator 905/916 Metrohm
Detektor ng Endotoxin PKF-96 ACC
Salaan ng Air Jet 200LS Hosokawa alpine
metrong pH PHS-3E REX
Conductivity Meter DDS-307 REX
Temperatura at Humidity Cabinet Climacell 707 MMM
Labonce-380GS Labonce
LHH-250SD BLUEPARD
CTHI-150B CONTACT



Audit History


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