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Case Study:
ICH stability storage at Q1 Scientific

Optimized Stability Storage

Facing space constraints and regulatory pressures, a healthcare manufacturer turned to Q1 Scientific. By outsourcing stability storage to Q1 Scientific, they reduced costs, maintained quality standards, and concentrated on their core competencies — all while benefiting from Q1 Scientific’s expertise.

Challenge

A leading healthcare manufacturer was running out of stability storage space at their site due to the prioritization of space for manufacturing operations. A decision was made to move the stability storage to leasable temporary units outside of their building that included three walk-in storage chambers at ICH conditions, costing them roughly €250k annually. Due to the stability storage chambers being outside the building in temporary units difficulty maintaining ICH
conditions was exacerbated in the heat of summer and cold of winter. These stability storage chambers were frequently alarming due to being out of specification, often outside of regular work hours. The healthcare company wanted to avoid a regulatory headache down the road and find a more secure, reliable and cost- effective stability storage solution.

Solution

The healthcare company partnered with Q1 Scientific after seeing the benefits of outsourcing to an industry leader in storage with 24/7 monitoring, integrated backup systems and an expert team delivering secure,reliable and cost-effective stability storage solutions. The customer transferred all their stability samples to
Q1 Scientific and saved significant costs in the process, turning CAPEX into OPEX.

Outcomes

By outsourcing its stability storage to Q1 Scientific, the healthcare manufacturer:

  • Eliminated the need for purchasing, installing or validating new stability chambers or cabinets, saving time and money.
  • Ensured that their stability samples were stored and handled in accordance with the highest standards of Good Manufacturing Practice (GMP) and the relevant regulatory guidelines and standards.
  • Mitigated the risk of stability chamber or cabinet malfunction or failure, which could compromise the integrity and safety of stability samples and data.
  • Freed up valuable resources at their site that could be used for other purposes.
  • Focused on their core competencies and strategic goals, rather than on the operational aspects of stability storage.
  • Accessed the expertise and experience of Q1 Scientific to provide them with customized solutions, best practices and market insights for their stability storage needs.

Client Testimonials

Q1 Scientific has provided us with an excellent resource for stability storage. The staff are very knowledgeable and friendly and show a great interest in our business. The security provided for critical samples is first class and allows us to know that our samples will be kept at the required conditions for the duration of our stability studies”

Technical Manager,

Leading Pharmaceutical Company