Pharmaceutical stability contingency and disaster recovery

Mitigating the risks in pharmaceutical stability storage

16 June 2020

Stability studies play a fundamental role across the lifecycle of pharmaceutical products, in particular during development and IND / NDA submission activities. Stability testing assesses how the quality of a drug substance or drug product (including its packaging) varies with time under the influence of environmental factors, including temperature, humidity, and light across a variety of conditions. The process determines whether any physical, chemical, or microbiological changes affect the efficiency and integrity of the final product, thereby ensuring that a pharmaceutical product is safe and effective, irrespective of where in the world it will be supplied. Moreover, stability testing establishes the shelf life and recommended storage conditions of a finished pharmaceutical product and the retest periods for a drug substance and ensures compliance with international regulations that form part of the registration process for a new drug substance or drug product.

Potential risks

Considering the financial and resource-related investment in stability programs it is important to identify all potential risks and their impact, prior to beginning a stability program. These include the potential loss of data from valuable products that have been in stability storage for several years, disruption to the continuation and integrity of the stability trial and delays associated with achieving successful regulatory approval.

Mitigating risks

Establishing and implementing a rational recovery plan in the event of a disaster or emergency for pharmaceutical stability storage is key to success. This should address all potential sources of risk. Additionally, the creation of contingency storage at a second site is an essential requirement that helps to de-risk stability programs against a range of possible challenges. This second site may be well an external provider which can offer a cost-effective solution. Outsourcing can be effectively de-risked by thorough client audit and close collaboration to ensure that a customized, responsive, disaster recovery procedure is established to cover any emergency transfer of samples between sites, which may scale from individual batches to entire chambers of samples should your own stability capacity be impacted.

Key considerations

Your partner should demonstrate excellence in quality, effective project management, knowledge of regulatory guidance and be able to offer the flexibility required in both storage conditions and capacity. Responsiveness and good communication are vital factors in the relationship that can help avoid any interruption to your stability studies as part of an effective risk management strategy.

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Dina Mistry,
Stability Manager

 

Today's expert blogger is Dina Mistry, Stability Manager at Intertek Melbourn. Dina leads the stability team and manages the stability programs at Intertek Melbourn providing storage support both internally and externally to a wide range of clients. Prior to joining Intertek, Dina held several team leader roles within the Pharmaceutical industry (Sanofi, Genzyme) within the analytical chemistry groups. She holds a BSc in Medicinal Chemistry from Nottingham Trent University.