qualification and documentation
Plant construction for the pharmaceutical and cosmetics industry is our profession. With more than 20 years of expertise, first ideas become products of the highest quality.
Which project can we support you with?
Planttech Engineering GmbH - Headquarters
phone: +49 (0) 25 92 / 91 505-0
Both documentation and qualification are meant to guaranatee your product quality. We check official regulations, as it is a requirement for product approval, e.g. by the FDA. Before documentation is prepared, a risk analysis is basis for your qualification plan.
These define further steps of qualification, which are:
If you need further assistance, we even support you in PQ. When performing above mentioned testing, we stick to the points given in risk analysis, user requirement specification (URS) and further documents. When your plant is already in use, we support you with change control (cc) management.
Feel free to contact us!
Martin Eßmann is expert for pure media, especially purified water.
Being founder and shareholder he is performing as an expert for planning and documentation of pure media systems.
Since 2000, he is also part of well known „GMP-Verlag“ (publisher for GMP-topics):
12/2009: Pharma+Food – Technische Dokumente bei Reinstwasseranlagen
04/2016: Edition Cantor Verlag – Anlagenelement und Normen: GMP-konforme Ventile, Rohre und Rohrverbindungen
06/2017: GMP-Praxis – Verfahrenstechnische Ausrüstung