QUALITÄT DURCH WISSEN UND ERFAHRUNG
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GMPLAN GMBH

 

gmPlan GmbH offers services for interested parties in health care and consumer protection to assure quality, efficacy and safety of regulated products - particularly Medicinal Products and their Starting Materials.

The main focus of our activities is on GMP Auditing & GMP Consulting (GMP - Good Manufacturing Practice). Our internationally acknowledged experts manage global projects in this field for more than 15 years

 

 

MANAGEMENT

 

Karl Metzger is Managing Partner at gmPlan GmbH with his focus on GMP Auditing & Consulting. He is Qualified Person according to article 14 German Medicines Law and an APIC-certified ICH Q7 Auditor with more than 15 years experience in global auditing.


Karl Metzger graduated in Chemistry (Dipl. Chem.) from the University Kaiserslautern, Germany in 1989. After several years in biochemical research and analytical development he joined BASF Pharma in 1995 as GMP/DMF Coordinator in the Uetersen site. From 1997 to 2001 he worked as project manager in the area GMP Training & GMP Consulting: first for Concept Heidelberg with his focus on API and Documentation, second with TDH/EuroEngineering and his focus on Qualification/Validation of API plants.


He worked for Welding GmbH & Co. KG in Hamburg from 2001 to 2010. There he was Management Representative for Welding's integrated Management System (covering GMP, HACCP, ISO and SHE requirements), Head of Production, and Deputy QP for APIs.


Furthermore Karl Metzger was active in several national and international federations (e.g. in the Good Trade and Distribution Committee of FECC, the European Association of Chemical Distributors).

 

 

PORTFOLIO

 

Please find below a list of different services provided by our experts. Please feel free to contact us to obtain taylor-made offers meeting your requirements.

  • Execution of Audits (e.g. GMP Compliance)
  • Survey of 'Status Quo' (as-is-analysis)
  • Execution of Feasibility Studys
  • Moderation and accomplish of Risk Analyses
  • Basic Engineering
  • Support on Supplier Qualification
  • Qualification of facilities, utilities and equipment (e.g. storage areas)
  • Support on Process Validation
  • Personnel Training (e.g. training to GMP and GSP)
  • Establishment of Quality Management Systems
  • Organizational Consulting
  • Support on certifications
  • Compilation of regulatory documents (CTD)

 

 

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