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News from the GMP world

58707739 - grunge gmp (good manufacturing practice) stamp


Introducing quality management or a quality management system (QMS) is a complex project. What is essential for you to consider?


  • Effective performance in production
  • Cost savings by means of fewer errors or complaints
  • Better fulfillment of customer requirements
  • Customer satisfaction/customer loyalty
  • Compliance with legal regulations
  • Involvement of the employees
  • Greater employee satisfaction

Which costs:

  • Personnel expenditure
  • External consultants
  • Certification/audit

Important milestones in the project:

  • Quality policy and quality goals
  • Definition of key data/figures
  • Stakeholder analysis and stakeholders
  • Determination of risks and opportunities
  • Creation of the documentation
  • Determination of customer satisfaction
  • Supplier evaluation
  • Definition of quality inspections

Introduction – the most important steps:

  • Clear definition of goals for the QM system
  • Information of the employees regarding introduction of the QM system by the management
  • Time schedule with main points
  • Description of the processes and the documentation by employees
  • Qualifying employees or external support by consultants
  • Monitoring of the project’s progress
  • Project manager ensuring compliance with requirements, standards and regulations
  • Selection of certification company and auditor
  • Date for certification

After successful introduction of the quality management system, it will be improved continuously. Quality management is always ongoing.

Correctly planned, implemented and successfully inspected

During your next preparations for audits and inspections, think about adaptation of altered general conditions, check your manufacturing processes (compliance check) and, above all, check your entire documentation.

We can offer you:

  • Set-up of a QMS in accordance with EU or FDA GMP guidelines
  • Development of standard operating procedures (SOPs)
  • Creation of the QM manual
  • Critical eye on checking of existing processes and of the production procedure
  • Internal and external compliance risks are identified and evaluated
  • Identification and rectification of weak points and deficiencies (gap analysis)
  • Documents are carefully checked and supplemented
  • Processes and documents are made explainable for all involved employees
  • Performance of self-inspections and accompaniment of official inspections

You have questions on the quality management system or are looking for support here. We will be happy to help you personally.