Too often, the term “closed process” is thrown around without an understanding of the salient issues. Pharmaceutical process closure can certainly provide many benefits, but there are various impacts and requirements depending on the ultimate goal and the specific process you are trying to close.
In regulated environments, companies are expected to establish procedures for document change control as a way of ensuring product quality and safety. Any changes made to the product, system or facility, (e.g., manufacturing, processing, quality assurance/quality control, information technology (IT), etc.) need to be documented in a timely manner. Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times.
We have been talking about Personalized Medicine for years. “Wouldn’t it be better if the medicine that I was taking was designed just for me?” We all know that personalized medicine would greatly benefit individual patients.
Learn how the application of best practice design principles can help mitigate the risks confronting biotechnology companies when navigating the uncertainty surrounding the demand profile of the product pipeline.
To ensure the quality of pharmaceutical raw materials and products, it is very important to monitor specific factors throughout the supply chain. In cold chains, temperature is closely controlled and monitored.
In the past 5 years, the biopharmaceutical industry has seen unprecedented change. Precipitated by the need to support a global client base with products that are more targeted, efficacious and cost-effective, the challenge to have a robust manufacturing supply chain is more crucial than ever to a company’s survival.