Use of Acceptance Sampling Plan for Stability Studies

• Activity Number: 133
• Type: Contributed
• Date/Time: Monday, August 5, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Frank Ye*+
• Companies: Amgen
• Keywords: CMC ; Acceptance Sampling Plan ; Stability ; Device Functionality

Abstract

Similar to traditional pharmaceutical dosage forms, combination drug products that are comprised of two or more regulated components and intended for concurrent use, such as prefilled syringes, autoinjectors and inhalation products, are legally required to be subjected under stability testing to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors. What is unique about the testing of a combination product is the additional of a set of functionality tests that can include physical properties like injection time, deliverable volume and activation force. For lot release, a statistically sound sample size of these tests is generally derived based on the theory of acceptance sampling plan. When the same rational is applied to stability studies, the sample size however becomes unnecessarily excessive for the purpose of reconfirming the quality of physical properties. In this presentation, we will examine the issue of multiplicativity for consecutive sampling plans and how a more reasonable sample size can be derived for a stability study of physical properties of a combination product.