Stability testing is an essential part of clinical trials, whether you plan to market your product in the U.S. or abroad. Unfortunately, because stability testing involves studying how a product changes over a long period, it’s inherently time-consuming and can monopolize valuable in-house resources. For many manufacturers, the logical solution is to outsource this process. Below, we look at three reasons you may want to outsource your company’s stability testing.
Free Up Your In-House Team
Stability testing requires you to test your product under different environmental conditions—including changes in temperature, humidity, and light—at scheduled intervals for up to five years (and sometimes even longer). If you’re planning to sell your product in different climatic zones as defined by the ICH, you’ll also need to conduct stability testing with regard to each of the zones where your product will be available.
If you conduct your stability testing in-house, it can take team members away from other projects and may not be cost-effective unless you’re running many stability tests at the same time. Fortunately, stability testing doesn’t require a lot of manufacturer oversight, which makes it a good process to outsource. When you outsource to an independent testing lab, your in-house team will have more time to spend on their core competencies.
Access Necessary Storage Space
Some drug manufacturers are motivated to outsource their stability testing in part because they don’t have enough temperature-stable units to house their samples. A third-party analytical lab should have storage units for both standard and accelerated stability testing and should be able to support a wide range of environmental conditions based on ICH guidelines. The lab should also have reliable backup power systems in place to prevent samples from being compromised in the event of a power surge or outage.
Work with Stability Testing Experts
One of the biggest benefits of outsourcing your stability testing is getting the opportunity to work with analytical testing experts. Analytical labs like Avomeen have extensive experience with both routine and non-routine stability testing. Additionally, analytical labs typically have the equipment and expertise necessary to perform accelerated stability testing, which can shorten your product’s time to market.
What to Look for When You Outsource Your Stability Testing
Outsourcing your stability testing means maintaining a working relationship with a third-party lab for years, so make sure you choose a professional partner you can rely on. Here are a few things to look for in your independent testing lab:
- Years of experience with stability testing
- A great track record for client satisfaction
- The ability to adapt their stability testing to a wide range of products and industry requirements
- Complete transparency and a willingness to answer your questions
You can find out more about how Avomeen meets these requirements—and goes beyond client expectations—by contacting us. Fill out our quote request form to learn more about our stability testing services.