Creating a disaster recovery plan in the event of an unforeseen emergency, when considering stability storage is key to the success of the study. This should include a thorough investigation of all potential sources of risk to understand what needs to be put in place to mitigate these. Additionally, adding a contingency storage plan at a secondary site is essential and will help to de-risk stability programs against a range of potential issues.
The second site could be an external storage provider, which can offer a cost-effective solution. Outsourcing can be effectively de-risked by doing a thorough client audit and working closely to ensure that a tailored, efficient, disaster recovery plan is established to cover any emergency transfer of samples between sites; which could include individual batches to full chambers of samples should your own stability capacity be compromised.
Identifying Potential Risks
The potential risks involved that could cause damage or complete loss of products that may have been in storage for a number of years, due to unforeseen circumstances, can have long term effects for an organisation participating in pharmaceutical development. Some events that may present a risk to the continuity of stability studies include:
- Extreme weather
- Flooding
- Fire
- Electrical failures
- Power outages
- IT systems failure
- Human error
Understanding the Impact of Potential Risks
Due to the sizeable demand on time, resources and financial investment; it is vitally important to identify all potential risks and their specific impact, in advance of setting down a stability program. These potential risks include but are not limited to:
- loss of valuable product
- Disruption to the continuation and integrity of the study
- Disruption to operations, including costly downtime
- Delays associated with gaining regulatory approval and market launch for the product
Having the ability to circumnavigating these risks will be largely dependent on implementing a robust disaster recovery plan. Additionally, establishing a partnership for contingency storage at a secondary site will dramatically help to de-risk stability studies.
Business Continuity Planning (BCP) is a recognised strategy, by which an organisation will recover and restore interrupted critical operations within a predetermined time period of any disaster scenario and is particularly relevant to long term stability studies.
BCP involves five main elements:
- People: key contacts with correct contact details
- Premises: recovery operations
- Process: for returning organisation to minimum service levels
- Publicity: internal and external communications
- Partners: key contacts in the supply chain, in this case, “partners” include the stability storage partners you select.
Pharmaceutical stability studies can be extremely complex, they require considerable financial investment and time, along with the correct level of internal expertise. Any disruption to these studies, small or large, could have serious repercussions on a product’s development timelines, which could have a serious impact a product’s market launch.
For organisations who have the capability to perform ICH stability studies in-house, the need to reduce risks associated with these studies can be greatly reduced through working with outsourcing partners with large capacity stability storage. These partners will have the ability to offer responsive and efficient relief storage in the event of a disaster.
Selecting a Stability Storage Partner
When selecting a storage service partner, there are some considerations you should acknowledge. These will help to secure a suitable and robust back-up resource to your existing stability operations. Auditing potential partners are an important process to assessing the services they provide. Site visits are also imperative and will give you an opportunity to review the following in detail:
- Quality systems
- Staffing capacity and employee training programme(s)
- Corrective and preventive actions programme
- Document control with a specific focus on stability storage,
It is also key to consider storage providers who have a proven track record of managing stability studies. When visiting a partner’s site, the following should be focused on:
- Stability program administration
- Chamber capacity and storage conditions
- Chamber security, alarm and back-up systems
- Operation, maintenance and calibrations of stability chambers, freezers and refrigerators
- Environmental monitoring of stability chambers, freezers and refrigerators
- Qualification documentation (IQ/OQ/PQ)
- Each storage provider’s stability disaster recovery and client notification plan
- Knowledge of relevant ICH guidelines
If you would like to learn more about Disaster recovery contact us below or register for our free on-demand webinar here.
