Relocating Lab Equipment, Managing GxP Compliance and Operational Readiness

A biotech pharma industry required the relocation of 30 analytical devices (such as LightCyclers, workbenches, centrifuges, etc.) to a new operational space. The relocation had to be executed with minimal downtime, ensuring that all equipment remained GxP compliant and operationally ready post-move. Zamann Pharma Support was brought in to plan, manage, and execute the equipment move while adhering to strict timelines and quality requirements.

Challenges Faced

GxP Compliance: Ensuring all equipment met GxP validation and qualification requirements after relocation.
Requalification Timelines: Each piece of equipment required thorough testing and documentation approval to ensure operational readiness.
Operational Continuity: Downtime had to be minimized to prevent delays in analytical testing and release processes.

Zamann Pharma Support’s Approach

Pre-Move Risk Assessment: Conducted a risk assessment to identify critical equipment specifications and testing needs. Documented all devices and created contingency plans for alternative analytical testing if delays occurred.
Qualification and Validation: Developed change qualifications to validate equipment performance both before and after the move. Conducted pre-move testing to establish baseline specifications and post-move testing to verify readiness.
Structured Planning and Execution: Created a detailed relocation plan with timelines and milestones for requalification activities. Coordinated weekly meetings with stakeholders to monitor progress and address any challenges.
Documentation Management: Ensured all requalification documents were reviewed, approved, and archived promptly to meet GxP standards.

Results Achieved

Minimized Downtime: Equipment downtime was reduced to a minimum, allowing analytical testing to proceed without disruption.
GxP Compliance Maintained: All equipment met GxP compliance standards, validated through change qualification processes.
Operational Readiness Achieved: The relocated devices were requalified and approved on time, ensuring operational continuity.
Stakeholder Satisfaction: Clear planning and communication ensured alignment among all parties involved, delivering a smooth relocation.

Client Testimonial

“Zamann Pharma Support’s expertise was critical to the success of our lab equipment relocation. Their detailed planning, risk management, and requalification processes ensured compliance while minimizing downtime. We achieved a seamless transition without impacting our operations.”

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