Sample Sizes For Performance Testing Of Combination Products And Drug Packaging

By Mike Ulman

When developing combination products or evaluating primary packaging for drug products, it's crucial to assess their fit-for-purpose performance. International standards and pharmacopeial chapters emphasize functional performance testing that simulates real-world conditions based on the product's intended use. This simulation includes:

• Matching the drug's physical properties using placebos.
• Duplicating the expected number of punctures and needle size.
• Testing samples pre-conditioned with sterilization treatments, transportation simulations, storage conditions, and thermal exposure to approximate actual environmental exposure.

After determining the necessary design verification tests to ensure the combination product meets design input requirements or that the drug packaging adequately protects the drug product, the next step is justifying the number of test samples. This is a key design verification requirement. The process begins by deciding on the required reliability of the combination product or drug packaging's potential failure modes, which is essential for risk assessment.