Quality management system: GDP, GMP

We assist companies in establishing and monitoring a pharmaceutical quality management system (QMS) in line with current GDP and GMP guidelines.

Planned, implemented and inspected – with success

We support companies by planning, documenting and preparing  audits and inspections. We help them to adapt to changing conditions. We check manufacturing processes (compliance check) and much more. Our services include:

  • GMP consultancy / gap analysis for pharmaceutical companies
  • Development of QMS for pharmaceutical companies in accordance with EU GMP Guideline
  • Development of standard operating procedures (SOPs) and QM manuals
  • Quality management system audits and updates
  • Carrying out self inspections
  • Assistance with inspections performed by regulatory authorities

Customised, GMP-compliant quality management

Diapharm ensures that pharmaceutical companies get a quality management system that fits their needs. Our consultants develop QM manuals and standard operating procedures (SOPs) so that standardised processes reflect the individual workflows of the company. With expertise and efficiency.

Did you know: In addition to advising on quality management and GMP issues, Diapharm also assumes duties and responsibilities in your QM system, e.g., as the quality management officer.

Dr. Atila Basoglu
Senior Consultant · Qualified Person
Mag. Dr. Sabine Hinterberger
Senior Consultant


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