The update to Annex 1, “The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use – Annex 1: Manufacture of Sterile Medicinal Products” is perhaps the biggest change to the manufacture of sterile medicinal products in recent times and possibly the most important topic for many in the biomanufacturing industry now.
Since publication of the revised Annex 1 guidelines, queries have been raised by Subject Matter Experts (SMEs), during the biweekly BioPhorum Fill Finish Container Closure Integrity (CCI) workstream meetings regarding the impact of these changes on CCIT requirements.
In response to these queries the team decided to carry out a series of bench marking surveys. The purpose of these surveys was to allow SMEs of member companies to compare industry practices, review their own practices and offer an opportunity for continual improvement. Discussions on the output of these surveys allowed transparent, facilitated dialogue on the revision of Annex 1 regarding CCIT requirements.
This members only document serve as a reference document for existing and new workstream members and is a collation of responses surveyed, narrative and notes made during discussions between SMEs and where applicable guest speakers.