Good housekeeping – qualification and documentation
Quality and safety have utmost priority in pharmaceutical production. Professional, complete documentation is a ‘must’. Documentation is based on the FDA (Food and Drug Administration) requirements or the GAMP (Good Automated Manufacturing Practices) directive.
Our experts have extensive experience also in this area and assist you as our customer in the preparation of all required documents. All qualification documents are maintained in a database and updated regularly. Qualification proceeds in three phases:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
If you wish, we can also assist you during performance qualification (PQ).
Martin Eßmann is an expert in ultrapure water storage and distribution systems.
As shareholder of Planttech Engineering GmbH, he has been working intensively since 1998 on the planning and documentation of process plants in the liquid industry of the pharmaceutical industry. Since the year 2000 he is a member of the author team of the GMP publishing house and GMP consultant.
Martin Eßmann is co-author of 'Praxisbuch Reinstwasser - Planung, Realisierung, Qualifizierung von Reinstwasseranlagen' (420 pages. 2. Edition 2011) available from GMP-Verlag.
He also writes articles on current topics from time to time:
12/2009-Pharma+Food - Technische Dokumente bei Reinswasseranlagen
04/2016-Edition Cantor Verlag - Anlagenelement und Normen: GMP-konforme Ventile, Rohre und Rohrverbindungen
06/2017-GMP-Praxis - Verfahrenstechnische Ausrüstung