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Projects

Biotech Research and Development Facility

Confidential, Jerusalem, Israel

IPS provided validation planning and design review services to ensure the design meets FDA and EMEA regulatory requirements and Current Good Manufacturing Practices. Additionally, our team developed a risk-based validation approach. In accordance with the client validation general policy, the IPS team developed a site validation master plan which detailed the overall approach to specification, design, construction, commissioning and qualification of the new facility.

 

  • IPS Provided the flexibility and the manpower to meet the biotech pilot facility project’s aggressive timeline
  • Worked with the design firm to complete the BOD and develop a template for user requirements
  • Established design review procedures and forms
  • Performed CGMP reviews on the equipment design packages
  • Established a risk-based approach to specification, design, construction, commissioning, and qualification
  • Provided access to vast biotech expertise required for biotech-specific validation activities
Client Name: Confidential
Region: EMEACountry: United StatesOffice: Blue Bell, PA
Services: Commissioning, Qualification & Validation, CQV Program Development, Regulatory Assessments, CGMP AuditsIndustry: Biotechnology & BiomanufacturingFacility Types: Manufacturing, Research & Development
Client Name: Confidential
Region: EMEACountry: United StatesOffice: Blue Bell, PA
Services: Commissioning, Qualification & Validation, CQV Program Development, Regulatory Assessments, CGMP AuditsIndustry: Biotechnology & BiomanufacturingFacility Types: Manufacturing, Research & Development

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