The data used to determine the success of a cleaning validation is built upon both the effective evaluation of the manufacturing plant and the robustness of the validated analytical method. In order to ensure the safety of the consumer, there must be a high degree of confidence in the analytical results in order verify the absence of residues at the prescribed limits on the various equipment surfaces. This white paper discusses the over-arching strategy for performing a successful cleaning validation, with detail on some of the key factors to consider at both the manufacturing and analytical stages, highlighting many common pitfalls to avoid.
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
Sometimes it's the smallest details that have the biggest impact on pharmaceutical performance. That's certainly true when it comes down to the properties of particles and their impact on pharmaceutical performance. Subtle changes in particle size, shape and distribution can have a major impact on pharmaceutical solubility, stability and efficacy.
Cross contamination must be avoided in the pharmaceutical industry at all costs. Successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood. Areas of concern must be addressed to ensure a successful outcome across the entire process.