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Dietary Supplement Storage Issues: Temperature Control

An excursion is a period when a product or ingredient is held outside of the appropriate storage temperature or humidity control.

When we talk about issues of temperature and humidity control as they relate to the storage of dietary supplements and their ingredients, we’re talking about what’s called an “excursion.”

Excursions are unpredictable because they’re caused either by human error or by an unexpected failure in technology, such as heating/ventilation/air conditioning breakdown or a failure in process or handling. (For example, moving a product out of an appropriately controlled environment for delivery, and encountering a delay in moving it to another controlled location.)

Excursions can lead to product degradation, which may include:

  • The development of impurities because of the degradation pattern, especially in tablets and other “dry”-type products.
  • The degradation of the product form, such as separation of components in liquids, potions or cosmetics.

These degradation factors may render a product ineffective and/or inconsistent with label claims.

Furthermore, if a product isn’t kept within appropriate storage specifications, it may become adulterated or inconsistent with label claims — or both. This can create a regulatory impact, leading to field alerts or potential recalls.

When an excursion occurs, the warehouse should have a way to determine the time of an excursion, the length of an excursion and what the excursion was, to help with the investigation to determine what the effect could be on the product.

Temperature Mapping

So what do we look for in a vendor when it comes to temperature and humidity quality control? Begin by asking about temperature mapping. How a vendor manages its storage conditions should be part of the vendor qualification or distributor qualification. Most large organizations use a temperature mapping system, which provides control over storage temperature and the ability to be alerted to and report on excursions. If they don’t have good storage practices, or if they don’t have the ability to control temperature and humidity and report on temperature and humidity control, that’s a red flag.

When an excursion occurs, the warehouse should notify the quality officer or department and immediately open an investigation. The investigation will determine the impact on the manufacturer’s product and everything in the warehouse that should be included in that investigation.

Once the investigation is done, you may or may not have to file a field alert, depending on what the situation is and if the product has been distributed. There may also be consideration for a recall.

This means you have to check to ensure that your vendor has this process in place, and you have to make that check part of your technical agreement. A vendor may be able to provide you with a paper trail for temperature mapping, but it’s good counsel to take it a step further and have a trusted source actually verify this information, both before you sign an agreement and on a regular basis thereafter. Put it in your technical agreement so everyone is on the same page regarding your expectations.

Risk Management Plan

In addition to the appropriate processes, your vendor should also have a risk management plan in place and should be able to show and share how that works with the manufacturer.

Your vendor may have the best systems in the world, but they need to expect the unexpected and plan for things such as:

  • The AC going down over a long break.
  • The heat going down, their warehouse having a brutally cold winter and everything freezing.
  • External temperatures becoming extremely hot and their air handlers not being able to keep up with cooling the facility.

Risk management also asks if a validation process or qualification process is in place that says, “We can have an excursion of up to X number of hours, and we know that the warehouse is still in control. Anything beyond that and we must apply extraordinary measures, such as fans or coolers, or relocating product to controlled trucks.”

Well-prepared warehouses have plans in place that support the ability to react to adverse events swiftly and effectively and communicate with you about those events transparently.

The Role of the GMP Audit

A GMP audit can help abate a lot of the risk involved with storage issues. A defined audit process completed by an independent organization, like NSF, determines audit duration, timeline for corrective action request (CAR) reviews and ongoing monitoring requirements. All of these help structure your response to a potential excursion and help you move swiftly in the event one occurs.

Remember: An audit is a lagging indicator for bad storage practices. By the time your audit discovers bad manufacturing practices, it’s too late. Hopefully, the vendor has a way to monitor its storage conditions, a way to monitor any excursions and a plan to make those excursions known to you, its customer, before an audit discovers and assesses the risk.

The takeaway from all of this is fairly simple. Storage excursions happen, they aren’t predictable and, as a result, you need your vendors to provide as much assurance as possible that they can detect and act on those excursions with tools like temperature mapping. You also want a clear plan for how they will investigate any excursion and how they will report on that to you. Ask to see their risk management plan and ask about their GMP practices and certification.

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