Use The Force, Luke!

With apologies to Trekkies and Warriors of the Star variety…

In the Stability Universe, we have pretty good control over our ship. We can train and order our crew to maintain and pilot the Stability Group vessel, charting a course through product design space and calculating shelf life, though no one has yet done that in terms of light years, not even Photo-stabilitarians. However, beyond our vessel and control are a plethora of characters we need for success. After everything that we can do by ourselves is in tip top shape, we ourselves cannot repair stability chambers, manufacture product for studies, modify a formulation, or accomplish dozens of other functions without the cooperation of stakeholders. We can identify over 30 stability stakeholder entities necessary to bring the registration of our medical products safely into port.

• Analysts
• Audit/Inspection Team
• Change Control
• CRO Liaisons
• Custodial
• Data Reviewers
• Facilities
• Formulators
• HVACs
• Informatics
• LIMS Team
• Manufacturing Schedulers
• Method Development
• Metrologists
• Microbiologists
• Packaging
• Project Team
• Quality Assurance
• Quality Control
• Reference Standards
• Regulatory Affairs
• Risk Management
• Security
• Shipping
• Stability Operations
• Statisticians
• Technical Writing
• Toxicology
• Validation Team
• Warehouse
• And many more…

You might think of some of them as Klingons, Romulans and Ferengi when you seek their help, as dealing with those outside of your organization can be a challenge. Organization cultural and language barriers are everywhere. There are few incentives for a stakeholder to prioritize stability needs above, or on a par with the competing needs of other groups.

Let’s take a relatively uncomplicated stakeholder function for example; like cleaning Stability Chambers. The tireless Custodial folks that clean our stability chambers are often those that may be less educated, paid at a lower rate, have English as a second language, are guided by general SOPs that may not be “stability cognizant” and could be unaware that they are an important contributor to developing lifesaving medications. They may be equipped with cleaning agents that could enter or interact with stability samples, could employ enough hot water washing walls and floors to significantly raise humidity or be unaware of the dangers in helping themselves to what appears to be a perfectly normal discarded OTC product. I’ve witnessed all of these scenarios come to pass.

On a different part of the spectrum, the Stability function charged with securing samples from a manufactured batch to initiate an annual commercial product stability study may rely on an unknown scheduler in a far-away plant. That person needs to be aware of Stability sample requirements, may or may not inform the Stability Group that no commercial batches are scheduled that year, or that a pre-selected batch was canceled after all previous batches were exhausted. They may also be hyper-diligent and flood the Stability area with unrequested samples from every batch, which draws regulatory objections. All of these situations have occurred on my stability watch.

These types of scenarios can and do play out across the entire range of stability stakeholders, contributing to Observations, 483’s and Warning Letters. Short of Jedi Mind Tricks, how do we minimize the possibilities of missteps and maximize consistent accomplishment of best practices and compliance?

To boldly go where not enough others have gone before, we need to invest in developing effective relationships, establish clear communications, engage in interactive execution of interdependent functions and daily stay on each other’s radar with our stability stakeholders. Consider spending significant time getting to know the needs, capabilities, and challenges of your stability partners.

With each stakeholder, there are unique measures you can take based on their procedures, priorities, and structure. It is well worth your time to identify your stakeholders and take those measures (meetings, e-mails, lunches, presentations, etc.) necessary to guarantee an effective and mutually beneficial partnership.