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Nagano Science helps you to identify, control and manage
risks in your storage stability testing process |
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Nagano Science helps you to identify, control and manage risks in your storage stability testing process.
Storage stability tests last for long periods and testing chambers are in operation 24/7 for years.
This means that samples are exposed to various risks for a long period. Any interruption during the test period may result in invalid or partial or even complete loss of storage stability testing data.
Not only would that incur a substantial increase of costs. At worst, it risks to delay the termination of quality control data, in turn causing delays in product registration and selling of the pharmaceutical product and significant loss of revenues for the company.
To help you to minimize and mitigate those risks, Nagano Science offers a total risk management program with assessment and risk control measures.
The program is based on applicable standards by the International Conference on Harmonisation (ICH), mainly Q8, Q9 and Q10, giving you a mechanism of defining, implementing and monitoring critical product quality attributes, quality assurance and quality control processes.
The result is a world-class operating structure, minimizing risks in the storage stability testing process and thereby saving your company cost, damage and loss of quality control data.
Nagano Science offers a full range of services, including:
● Risk Assessment
● Back-up storage
● Validation
● Daily inspection
● Operator training
● Documentation
Creation of QMS (quality management system) and SOP (standard operation procedure)
You can choose a full Risk Management program or any part thereof, depending on your needs.
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