CONSULTING

Technical Consultancy

Design analysis and technical studies to ensure compliance with the strictest regulatory standards in the pharmaceutical industry.

Analysis of regulatory requirements

Grifols Engineering will design and set up process controls (PLC programming, Scada systems and touchscreens), ensure adherence to FDA, cGMP (21 CFR Part 11), and apply FDA, cGMP (21 CFR Part 11) and GAMP4 standards where necessary.

Technical Studies

  • Conceptual designs which comply with these standards
  • Optimization of the facility design
  • Containment consulting
  • Sterile systems studies
  • Consulting in conformity with GMP requirements for machines and plants

Technical Training

Training equips your organization with the tools needed to run smoothly in terms of both production and compliance.

The professional team at Grifols Engineering offers specialized training in the following fields:

  • Risk analysis and application to the pharmaceutical industry
  • CIP systems and validation
  • SIP systems and validation
  • Pharmaceutical industry cleaning (fumigation, sanitization and cleaning systems)
  • Aseptic filling
  • Purification methods for biological products
  • Water treatment systems
  • Cleanroom designs
  • Control systems for pharmaceutical applications
  • HVAC design and classification