The qualification of equipment is a GMP requirement. Qualification is the documented evidence of the verification that a pharmaceutical machine meets the pre-determined requirements. The definition varies per guideline. For more information you can check the following documents; Annex 15 of Eudralex Volume 4 – LIFE CYCLE APPROACHEMA Process Validation Guideline for Finished Products ...
People often ask me what the most important GMP or GDP aspect is. I used to answer these questions with: Risk Management is key and must be incorporated throughout the whole Quality Management System. Or, I would answer that they should never forget to add and implement effectiveness checks within CAPA management. During the years, as a manager, I realized that how good your Quality Management...
The proceedings of the October 2017 meeting of the WHO Expert Committee on Biological Standardization (ECBS) have published the WHO Technical Report Series (TRS) 1011.
European Union health ministers raised concerns over the potential for drug shortages if the COVID-19 outbreak continues to keep China in a near lockdown.
Uncertain Times for British and European Pharmaceuticals. The outcome of the referendum on the departure of Great Britain from the EU not only surprised the financial markets completely, the European Medicines Agency (EMA) seems to have been somewhat overwhelmed by the development as well.
European Commission Chooses Amsterdam After Considering 18 Other Bids From EU-Member States. The move from the current offices at London's Canary Wharf will have to be completed within only sixteen months, right before the UK is set to leave the EU.
Biosimilar development is a consequence of the financial success of biologic therapies and their eventual patent expiration. The pharmaceutical industry must now develop complex biosimilars that resemble FDA-approved biologic agents and invent analytical tools and end points to demonstrate similarity to regulatory authorities. Already in development is a new wave of "biobetter" or "biosuperior"...
It's only February and already the European Medicines Agency (EMA), the U.S. FDA and other worldwide organizations such as the WHO, ICH and PIC/s have released a number of guidances. We've made a comprehensive list of these guidelines, their importance and possible changes as opposed to other versions.
This series of blog posts will introduce you to leadership in the pharmaceutical industry, this blog will provide an answer to the question: what are the expectations for senior management, based on the regulations?
FDA Reports Conducting Environmental Sampling In Warning Letter