Good Manufacturing Practice GMP is based on laws, guidelines and internationally harmonized standards to assure the quality of all production processes, premises and facilities in the production of pharmaceuticals, ingredients, medical products and cosmetics. GMP’s primary objective is to ensure the quality, efficacy and safety of the products and thereby the safety of consumers. The Quality Management System also serves to fulfill all the binding official requirements for the product marketing.

Your Challenge

Are you about to pass your regulatory inspection or is your operating license about to expire? Do you intend to change your supplier or manufacturer? Are you planning a new production facility that needs to qualify with the regulations or do you need to validate new or existing processes? Or do you lack the time and resources for your versatile and complex projects?

Our Service

Pharmatrend GmbH supports and advises you in the many aspects of quality assurance and pharmaceutical quality management. As an independent partner, we bring ourselves and our experience in the versatile GMP field:

  • Development, revision and maintenance of quality management documentation
  • Assessment and verification of suppliers, manufacturers and contracts
  • Annual evaluation of Product Quality Review (PQR)
  • Validation of manufacturing processes
  • Qualification of rooms, facilities, suppliers and partners
  • Attendance before, during and after regulatory inspections