Stability Intelligence May Be Your Smartest Move

One of the most intelligent moves I’ve seen a corporate Stability organization make was the establishment of a Stability Intelligence (SI) Specialist within its ranks. Someone whose primary responsibility was to continuously monitor the medical product world, its regulators and influencers for any inputs whatsoever regarding the Stability function and the establishment of shelf life and storage conditions. Their most common sources included:

• Regulations
• Guidances
• Compendia
• Publications
• Blogs
• Industry Associations
• Webinars
• Conferences
• Forums
• Discussion Groups

Potential goals of such a Stability Intelligence individual could include:

• Early warnings of impending requirements or changes to current requirements
• Regulatory findings of deficiencies and flaws among the world’s Stability programs
• Compile a list of events / sources of the latest in Stability thought and practices
• Identify common challenges experienced by industry Stability Groups
• Discovery or development of new approaches to the Stability Function
• Monitor new developments in equipment associated with the Stability Function·
• Identify qualified suppliers of Stability services and equipment.
• Disseminate SI information throughout Corporate Quality and Stability Stakeholders
• Work within the organization to identify and analyze the impact of the SI information

Your organization may already be approaching such an initiative in a haphazard fashion or on an “as time permits” basis. Not a bad or uncommon place to start, but risky in the sense that urgent matters or tight staffing budgets could eliminate or sharply curtail those activities. If a full-time position dedicated to this pursuit is not yet on the horizon,(which is likely the case with 80-90% of Stability programs) making room for it in the job description of one of your staffers with a passion for it is a good step forward.

Even as a subset of a job description, this activity could come under question from management as to whether it is the best use of limited resources. Therefore, it is important to establish a solid justification for this pursuit. One could start with the value of avoiding citations, loss of time and hence revenue, and conversely, the gain of those aspects when their organization is in possession of stability intelligence and using it well prior to the typical challenges. Monetary penalties, loss of first to market status and damage to corporate reputation are all factors to be employed in a well-organized justification.

So where to start? Make a low-key assessment of how your organization currently gathers stability intelligence and the degree of enthusiasm various members/levels of management might have for advancing the cause. Taking some components of your justification into casual conversation (“wow, did you see the Warning Letter/Fine CareFree Pharma just got for not having a stability monitoring system?”) can help ferret out some candid opinions. Developing an alliance with your Quality Organization is another important step. You certainly can use their help in this pursuit and without them having to commit resources, they may be a good sounding board and place to practice your arguments to see which ones are the most impactful

Start with your most capable and enthusiastic staff member to take the steps listed in the first paragraphs of this article. Task them to coordinate the monitoring of the multiple stability intelligence sources by having each of several stability colleagues take one or two sources to keep an eye on and report back any developments. Their involvement will sharpen their awareness of what’s impacting the stability function and how they may contribute to utilizing the information for the betterment of their organization. At regular group meetings, gather reports on recently gained intelligence and how you might take action to use it to your benefit.

Leak any good news from this initiative upwards, letting cumulative benefits sink into managerial minds over time until they start to encourage and look forward to this type of progress. When ready, muster your Quality allies, strongest justifications and solid intelligence-based track record to ask management to create the Stability Intelligence position. If not granted on the first try, don’t give up. Keep working with Quality and highlighting the impact that a strong intelligence program brings.

Here are a few interesting gains made by Stabilitarians when actively engaged in gathering Stability Intelligence. While at a Pharmaceutical Stability Discussion Group Meeting, a participant asked whether there had been any regulatory demands regarding requalification intervals of Stability Chambers. The individual wanted to requalify only when an incident demanded. Almost all respondents to the question did not encounter citations despite having a wide range of intervals and a Guidance that cited a 2-year interval. Only 1 participant was cited, and that was for having no requalification policy whatsoever. The important takeaway was that the key to success was to document a strong (data-based) justification for whatever interval policy they followed, including an “as needed” one.

A smaller instance, but important to appearances of control, was when on a host company tour, a participant noted that the corner of a window of a 40C/75%RH chamber was rusting, causing the host a degree of embarrassment when visitors or inspectors came through, The PSDG participant commented to the host: “we used to have that problem. The solution is to heat the glass in the window”. Problem solved. Other benefits of touring are asking the host how various practices are working out; things that would not have come to mind during a meeting session, but do when the “tourist” is standing just feet away from a process, piece of equipment or Good Documentation Practice in action.

Reviewing regulatory inspection observations/deficiencies should be a mandatory activity within pharmaceutical organizations and can go a long way to making your companies way more efficient with relatively small effort. For example, there are no regulatory guidances available that detail tolerances on removal of stability samples from storage chambers at their pull points and timings allowed for conducting and reporting analytical testing. However, a review of FDA “483 observations” indicates that over the years many citations and even warning letters have been issued on this topic. Discussions at meetings of stability groups have revealed that for both of these items, a number of different approaches are being applied by different companies, many of which have been observed and accepted during regulatory audits. Provided that companies detail their practices in SOPs and can present data that demonstrates that they are conducting programs in accordance with their SOPs, inspectors are generally satisfied that programs are well managed.

Polling at a discussion group meeting was very lively and passionate about test initiation timing. Some companies had 2 weeks, some 30 days. One company with 30 days had multiple incidents of late testing and after conferring with peers realized the significant audit risk they were taking.

By reading an article about water activity vs. moisture by LOD or KF, a stability manager became aware that their products could possibly forego expensive microbial testing since their product could be proved to be so dry as to not support microbial growth—a huge savings and risk reduction.

A quick review of regulations on in-use testing led a company to quickly modify their stability strategy to ensure they tested at least one batch near expiry to comply with EMA requirements.

Through a forum with peer stability organizations, a series of mock audits were arranged between stability programs that yielded a tremendous knowledge sharing initiative, giving groups much needed experience hosting an audit and bringing valuable compliance tips to all of the participants.

Stabilitarians and their stakeholders have a good grasp that their craft has a lot of room for interpretation, and some interpretations produce good results while others don’t come across as great ideas to auditors and inspectors. Only by sharing experiences can we home in on the best practices and discard the worst. The secret is to be among the sharers when the sharing is being done. Whether the educator or the educatee, seek out those times and places when information not found in any book flows freely among professionals striving to do their best for their patients, company and profession.

Use the full range of resources to glean the full range of information to attain the full range of benefits. Make Stability Intelligence a priority and it will yield satisfying and profitable results.