Quality management

Quality Services

Our QM-Team is experienced, innovative, cooperative, motivated.
We consult, support and take responsibilities in the following areas: Good Clinical Practices (GCP), Good Distribution Practice (GDP) und Good Manufacturing Practice (GMP). Please use our know-how and expertise.

We offer support in the following areas:

Quality Systems

  • Evaluation and optimization of existing Quality Management Systems.
  • Implementation of a Quality Management system from scratch

 

Quality Evaluations, Improvements

  • Gap Analysis, Audits / on-site Assessments
  • Knowledge of all national and international guidelines and requirements
  • Experience in the preparation, coordination and follow-up of international inspections from Regulatory Authorities
  • Excellent knowledge in the areas of biotech, FDF and API manufacturing, development
  • Risk Management, eg Annual Product Reviews, Complaint Trending, ICH-Q3D
  • Impact assessments, eg during change control

 

Supplier Audits, Due Diligence Audits

  • Experienced and international Team 
  • Excellent knowledge in the areas of biotech, FDF and API manufacturing, development
  • Audit CAPA Tracking

 

Batch Release and Batch Certification 

  • We take full responsibilities for batch release /Qualified person (14 AMG) service after notifying the respective Regulatory Authorities
  • Batch Certification and release with QP declaration
  • Batch release of clinical studies
  • Batch release for special products, eg biologics
  • Batch release testing and certification
  • Import Release for finished products for companies located outside the EU /EWR

 

Wholesale Responsible Person according AMG §52a

  • Act as Wholesale Responsible Person
  • Implementation of GDP Systems

 

MAH, Marketing Authorisation Holder 

Interesting offer for manufacturers or companies, which:

  • need a compliant QA Management system according to Good Manufacturing Practices (GMP) or a compliant Pharmacovigilance System
  • are manufacturers outside the European Union (eg Suisse, US, China, India, etc) and intend to launch products within the European Union (EU / EWR) 

 

Training

Execution of Trainings and Workshops in the area of:

  • Quality Systems
  • GMP initial training and refreshers
  • Pharmaceutical law
  • Good Distribution Practice

Your Contact

Dr.  Christian Fabian

Dr. Christian Fabian

Quality Management & GMP-Services
Director

Midas Pharma GmbH
Rheinstr. 49
55218 Ingelheim
Germany

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