Pharmaceutical Storage & Transit: Conditions for Consideration

During the drug development process, it is imperative that your company determine the appropriate conditions for storage and transit of your products. The best way to discover optimal conditions is to conduct small-batch testing under a number of changing environmental situations. There are several factors to consider. Let’s take a closer look.

Number and Size of Batches

As part of good quality assurance procedures, pharmaceutical manufacturers must perform regular stability testing. Generally, you should place a minimum of three initial batches into a long-term stability program to ensure batch uniformity. This control helps establish an expiration date and environmental storage conditions.

Accelerated Studies Performed

Manufacturers typically use an accelerated process of environmental changes, including temperature. Benefits of acceleration include:

• Reduced lab time
• Money saved by bringing products to market more quickly
• Faster determination of appropriate storage conditions before products are tested

Test Intervals

Good Manufacturing Practice (GMP) advises that you run stability tests at least once a year. They more strongly recommend that testing be performed:

• Directly after manufacture
• Every 3 months for the first year
• Every 6 months for the second year
• Annually thereafter

Storage Conditions
You may be tempted merely to state that your product is stored at room temperature. Here’s the problem: that can range between 15°C and 30°C. A product stored for stability at 15°C may have quite a different stability profile at its expiration date compared with a product stored at 30°C. Therefore, always record actual temperatures within your test studies.

Test Methods

Test methods should be accurate, specific, and reproducible. They should always include a stability-indicating procedure to distinguish the active ingredient from any degradation products. Finally, manufacturers and repackagers must maintain good records of all analytical procedures, since ultimately, you are responsible for the quality of your products.

Container-Closure Systems

It makes sense that environmental testing for stability should occur in the same enclosures (e.g., bottles, vials) that will be used when you market your product. FDA policy, however, does allow repackaging in container-closure systems that are at least as protective as the original system—without performing new stability studies prior to marketing. For instance, you may repackage solid dosage units from plastic containers into glass containers, because glass is a superior barrier to moisture and gas.

Container Sizes to Be Tested

Smaller marketed containers are more vulnerable to product degradation because of a higher internal surface area to volume ratio. For example, moisture penetration through a 4 oz. bottle of tablets can be more detrimental than moisture penetration through a larger bottle. For this reason, testing the smallest container size is a GMP imperative.

Preservatives and Other Inactive Ingredients

Pharmaceuticals often contain substances other than the active chemical (e.g. desiccant, preservatives). While most of these additives have no chemical effect on the stability of the product, they should be monitored throughout their shelf life to ensure their effectiveness.

Read Our White Paper

Sophisticated pharmaceuticals are an extremely valuable cargo—both to your company and to patients. Lack of clear regulations concerning correct storage can result in an expensive loss of product or revaccination of entire populations. At the same time, practical information on the consequences of improper storage of drugs is scant at best.

Download our white paper, The Importance of Temperature Monitoring for Medication Safety and Efficacy.