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, CGMP AuditsIndustry: Biotechnology & BiomanufacturingFacility Types: Manufacturing, Research & Development
Region: EMEACountry: United StatesOffice: Blue Bell, PA
Services: Commissioning, Qualification & Validation, CQV Program Development, CGMP AuditsIndustry: Biotechnology & BiomanufacturingFacility Types: Manufacturing, Research & Development
Project Details
Client Name: Confidential
Region: EMEACountry: United StatesOffice: Blue Bell, PA
Services: Commissioning, Qualification & Validation, CQV Program Development, CGMP AuditsIndustry: Biotechnology & BiomanufacturingFacility Types: Manufacturing, Research & Development
Region: EMEACountry: United StatesOffice: Blue Bell, PA
Services: Commissioning, Qualification & Validation, CQV Program Development, CGMP AuditsIndustry: Biotechnology & BiomanufacturingFacility Types: Manufacturing, Research & Development
