Establishing and Managing the Drug Product Stability Budget
This article from CoolPack Technical Advisor, Dr. Rafik H. Bishara discusses the drug product stability budget: the allocation of time out of storage for each step of the manufacturing and distribution of the drug product.
How long can a pharmaceutical product be exposed to temperatures outside the recommended storage conditions? How can product discard be prevented in cases of temperature excursions? How to establish and to manage the allowed time out of storage of a pharmaceutical product? The short answer is: It all depends on the chemical and physical properties of the product, the knowledge about product stability and the presence of temperature exposure data. In this article, the science behind the establishment of a stability budget for products that need to be maintained under controlled temperature conditions will be explored and guidance will be provided to manage the product stability budget in the (bio) pharmaceutical supply chain.
Source: Pharmaceutical Outsourcing