With the publication of the draft revision of Annex 1, a term emerges that has not previously been present in this intensity in the guideline - "https://www.gmp-compliance.org/gmp-news/press-announcement/the-new-ubiquitous-term-in-aseptic-manufacturing-contamination-control-strategy.html">Contamination Control Strategy".
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Medicines Agency (EMA) stated that they would set up a number of measures to deal with the further nitrosamine issues that recently have been emerging.
Although the regulations with regard to qualification and validation are different in the US, in Europe in China and other countries, the core thinking is similar. And what these activities have in common is that they can cost a lot of time and money. A new ECA Guide aims to simplify qualification and validation activities. Special service for participants at the launch conference: get your free download of Jettconsortium templates.
The qualification of equipment has been a regulatory requirement for many years. Although the revision of Annex 15 today allows significantly more flexibility in equipment qualification, it is often still very static and complex. The new ECA Integrated Qualification and Validation Guide will help to change this.