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Stability Testing Seminar

What is Qualification in the Pharmaceutical Industry?

In association with Weiss Pharmatechniik, DACTEC hosted a seminar on 26th September 2013 on Stability Testing.

The seminar considered stability testing in compliance with ICH (International Conference on Harmonisation) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, EU GMP (Good Manufacturing Practice), GAMP5 (Good Automated Manufacturing Practice), FDA 21 CFR Part 11 (An American set of rules governing the prevention of corruption and loss of data) and EU GMP Annex 11 in Practice.

Delegates came from all over Ireland to Bewleys Hotel in Sandyford, South Dublin for the seminar, which ran for 6 hours.

After a brief introduction by Dave Toner, MD of DACTEC, Michael Holzwarth, Sales Manager of Pharma Chambers in Weiss, gave a very interesting series of talks.

Topics Cover

  1. Modern Stability Testing for Pharma and Biotech Companies. Requirements and standards are rising all the time and are at present far above the level of 20 years ago. We discussed the current best practice.
  2. Innovative Stability Test Systems. How the current best chambers raise the bar e.g. Votsch‚ have unique fully compliant 2013 VP series.
  3. Equipment Qualification according to GAMP 5, FDA 21 CFR Part 11 and EU GMP Annex 11 in Practice. Topics surrounding the qualification/testing of stability chambers and monitoring systems in a compliant manner. See our blog ‘Chamber Mapping & Qualification‘.

None of these topics are simple, as they are not specified in sufficient detail by auditing bodies so as to be easily defined for every site and application. This is why this seminar was invaluable to the participants.

The delegates asked many questions and the feedback was that they found it very informative and helpful.

All delegates later received a CD with the presentations and a certificate of attendance.

If you would like to suggest the subject of a future seminar, or are interested in attending any future events, please Contact Us.

See our Stability Chambers here and you might also be interested in our blog ‘Stability Testing – An Overview‘.

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