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

Our Services

We support you with training and advice during the whole process so that the audits and all processes can be conducted through staff after the project is finished.

Product / Process/ Facility

  • Build up a Quality Management System,
  • Development of product & process specifications conform German (EU GMP) regulations,
  • Set up the ideal EU-GMP-process around your products, Building the fully EU-GMP-compliant facility around your processes (longterm cooperation with EU-GMP compliant architects office in the pharmaceutical industry),
  • Planning and conducting of quality and operational processes.

Organisation & Documentation

  • Project management and realisation for all stages (development to implementation of GACP-/EU-GMP-/GDP-concept),
  • Development of High Level Documents (Site Master File, Validation Master Plan, Business Plan) and the necessary basic documentation (technical/process/quality management),
  • Longterm cooperation with supplier and companies from the pharmaceutical industry,
  • Partnership with SIEMENS, own tool „CVal“ for creating a digital twin (for optimization and simplifying the set up and datamanagement),
  • Selection and establishing of analysis methods

Supplier management

  • Developing, establishing and conducting a supplier management process for you,
  • Planning and conduction of supplier audits,
  • We can be your link through our network of various EU-GMP-compliant suppliers from the pharmaceutical industry and the European Cannabis Association (ECA)

Regulations

  • Integration of companies familiar with local building regulations,
  • Supervision of building progress regarding EU-GMP-compliance,
  • Legal advice through cooperation with DENTONS (lawyer´s office)

Continuous Consultancy

  • Prepare the organisation for audits through authorities
  • Conduct audits on a regular base to maintain and check high quality status (like once a year)