GACP and GMP knowhow

The realisation of GACP and GMP is multi-layered and complex in its implementation. As a longterm partner of researching and producing pharmaceutical companies we understand the related tasks:

  • Process design and optimisation
  • Development and transfer of knowhow
  • Time and cost controlling
  • Covering of resource bottlenecks

We solve all GACP and GMP relevant organisational issues goal oriented and do offer the opportunity to set up an agile service for projecting. We develop and create relevant operating instructions, processes and specifications, and conduct the corresponding qualification and validation.

GMP

  • Design of processes in the segment of product substance according to specific GMP guidelines
  • Development and preparation of specifications
  • Setup of a GMP organisation incl. implementation and establishment of QM processes
  • Qualification and validation

GACP

  • Design of processes in the segment of drug substance according to specific GACP guidelines
  • Support for business plan preparation
  • Development and preparation of specifications
  • Setup of a GACP organisation incl. implementation and establishment of QM processes
  • Qualification and validation

Research & Development

  • GMP-based processes in the area of research and development
  • Selection of analysis methods (incl. supplier selection)
  • Setup of a laboratory structure for analytics
  • Establishment of analysis methods
  • Online measurement methods
  • Evaluation and statistics based on analysis
  • Method validation
  • Qualification and validation