QUASAAR receives FDA APPROVAL

AUGUST 2019 QUASAAR receives FDA APPROVAL

Quasaar received official FDA approval for the successful audit this May.

As a next step, in 2020 we aim for the ANVISA certification

First Steps FDA-Approval!

Quasaar has registered with the FDA and expects the first audit.

Our FEI No .: 3014297892

New analytical techniques available

From September, a light scattering detector (corona detector) will be available.

Particle size determinations (laser diffractometry) are now also possible with toxic substances thanks to a professional safety cabin

Training & Seminars 2018

- APV: Data integrity in the laboratory, 13./14.06.2018, Wiesbaden

- APV: Basic Training Cleaning Validation, 19./20.06.2018, Wiesbaden

- APV: Correct and GMP-compliant handling of standard substances and reagents in the laboratory, 24./25.4.2018, Wiesbaden

Quasaar at Pharma Forum 2018

We present ourselves once again with a booth at the Pharma Forum.

This time in Saarbrücken and also with a short lecture on "Digitalization and data integrity - a challenge in the GMP environment"

We would like to welcome you to our stand!

Quasaar at CPHI in Frankfurt (24.-26. Oktober) and IPEC in Berlin (19.-20. September)

We present ourselves for the first time with a booth at the CPHI 2017 in Frankfurt as well as the IPEC 2017 in Berlin

 

We would like to welcome you to our stand!

 

Take the opportunity to meet our experts for a personal conversation.

We would like to present you in detail the latest developments as well as our flexible and innovative service.

 

To coordinate an appointment simply send a request to info@quasaar.de stating date and topic request. We take care of the further organization.

 

With this in mind, we look forward to meeting you in Frankfurt, Berlin or perhaps directly at our location in Überherrn.

New Equipment / 2. Line at Stability Center opened

 

In addition to the expansion of our analytical equipment (eg particle measurement: Sympatec, UPLC: Agilent / Merck-Hitachi, AFT-IR spectrometer: Bruker), we have further expanded our stability center.

Already at the beginning of the year, the 2nd chamber line (capacity expansion up to 1000 m3) was inaugurated, which new climates (eg 5 ° C) and expansion of existing climates (30 ° C / 65% rh, 40 ° C / 75% rh) allows.

Training & Seminars 2017

- APV: Korrekter und GMP-gerechter Umgang mit Standardsubstanzen und Reagenzien im Labor, 2./3.5.2017,Wiesbaden

- APV: Das unerwartete Event, OOX, Abweichungen und CAPA- GMP-kritische Prozesse kontrollieren! 3./4.5.2017, Wiesbaden

- APV: Basistraining Reinigungsvalidierung, 16./17.5.2017, Wiesbaden

- 2nd European Conference on Pharmaceutics „Novel dosage forms and innovative technologies“ 4./5.4.2017, Krakau

- Stabilitätsstudien für Praktiker, 07.09.2017, Klinkner&Partner, Saarbrücken

- Gerätequalifizierung Praxistraining, 28.11.2017, Klinkner&Partner, Saarbrücken/Überherrn

New Climatic Conditions established

    • 30 ° C / 65% r. h.
    • 50 ° C, 60 ° C (aging studies)

For 2018, the expansion of the stability center is planned for the following climates:

      • 5 ° C
      • 30 ° C / 35% r. h.
      • 40 ° C / 25% r. h.
      • Return sample storage 15 - 25 ° C

    2nd GMP audit of german authorities 20.11.2017 successfully passed.

    GMP certificate 2018

    GMP audit of german authorities successfully passed on 08.10.2015.

    Establishment of new analytical Technologies

      • New residual solvent method established! Generic method for analyzing all common residual solvents.
      • Establishment of bioanalytics in the second half of 2016

    Hot topic

    Experts demand higher standards of quality and monitoring of dietary supplements. Use our established analysis techniques and know-how.

    50% of medicines from Internet sources are counterfeit. We assist you in identifying counterfeit medicines.

    Stability center ready!

    • 280 m3 25 °C/60 % r. h.
    • 180 m3 30 °C/75 % r. h.
    • 50 m3 40 °C/75 % r. h.
    • New at August 2017: 15 m3 30 °C/65 % r. h.