Cleaning is a defining process in the changeover from recipes that contain an allergen to those which do not. This paper discusses the importance and steps required to design a successful cleaning validation programme.
During a manufacturing process unexpected and unknown impurities may arise in a sample. It is important that such impurities are isolated and identified.
In an industry that is seeing increasing levels of outsourcing, the contract research organisation (CRO) needs to have proven experience in both the pragmatism and flexibility of method development and a regulatory background in validation.
Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal analytical test used for detecting physical changes in an active pharmaceutical ingredient and formulated product