Smart, cost-effective and resource efficient validation to demonstrate regulatory compliance.
Whether it is a single, stand-alone equipment item or an entire facility, the GxPi team is able to support you with the planning, management and implementation of validation. With a huge amount of accumulated knowledge and experience, our team of validation project managers, validation engineers and validation scientists is able to help your business complete its validation requirements. GxPi can provide you with a team that has many years of experience in identifying, communicating, managing and delivering on how to best meet the regulatory requirements of the MHRA, FDA, EMEA, CDA, HTA, WHO and ICH.
We are able to provide you with a resource that has knowledge and experience that combines the discipline of project management with a comprehensive technical and regulatory understanding of the development, approval, manufacture, packaging, storage and distribution of pharmaceutical, biopharmaceutical, medical device, veterinary and homeopathic products. These services are available to you as part-time, full-time, interim and project-specific support services to suit your business needs.
• Corporate and site validation strategy
• Analytical assay method development and validation
• Preparation of the validation master plan (VMP)
• Process validation (PV) strategy and master plan preparation
• Cleaning validation (CV) strategy and master plan preparation
• Interim and part-time validation manager support facilities (on-site and remote services)
• Validation project management
• GXP (GLP / GCP / GMP) risk assessment and impact assessment
• Equipment validation (e.g. autoclaves, lyophilisers, spray dryers, packaging lines, filling machines, LAF units, reactors, vessels, filters, dryers, coaters, ovens, laboratory equipment and much more)
• Utilities validation (e.g. HVAC, Clean Steam, CIP, SIP, Air, Nitrogen, Pure Water / WFI)
• Validation protocol preparation and implementation
• Contract validation manager services (interim, part-time or full-time options)
• Validation engineers
• Validation scientists