Annex 1 Perspectives et Mises à Jours
La Commission européenne a publié son projet d’annexe pour examen et commentaires. Nos experts ont examiné attentivement ce document et ont partagé leurs idées avec vous.
Voici quelques extraits vidéo que les experts de PMS ont rassemblés sur des sujets uniques couverts par l’annexe 1 Rév 12 2020:
- Update: Continuous Viable Monitoring
- Alternative Micro Methods and Rapid microbial
- Single Use Considerations and a solution
- Cleaning & Disinfection: What you need to know
- Classification – Qualification – Monitoring
- Quality Risk Management (QRM)View Page
- Science v. Standardization: Meeting auditor’s expectations by understanding the reasoning behind the rules
- Using a Risk Assessment to set microbiological plate incubation conditions
Restez à l’écoute pour plus de vidéos ou obtenez un résumé du projet de révision de l’annexe 1 des BPF de l’UE en lisant le document ci-dessous ou en regardant le webinaire (colonne de droite sur cette page). Nous avons également des FAQ avec des réponses ci-dessous. Voyez également ci-dessous pour certains de nos produits conformes à l’annexe 1 viables non viables.
Knowledge / Papers
Annex 1 Revision 2017 Comments from Industry Experts
The updated EU GMP Annex 1 Draft was released for public comment in December 2017, and the industry experts at Particle Measuring Systems have shared their response on the revision.
Concerned about how Annex 1 might affect you?
Industry experts answer over 40 common Annex 1 draft questions including:
- During cleanroom classification, is it mandatory to monitor viable and non-viable counts simultaneously?
- Can you choose not to use one of the microbiological sampling methods for qualification of a classified area?
- Does the removal of the 5 micron particle size from ISO 14644 mean the qualification time for Grade A and B will be vastly reduced?
- Have particle sizes greater than 5.0 been removed as a requirement of Grade A or B monitoring?
EU GMP Annex 1 Compliant Products
Cleanroom Microbial Monitor: BioCapt® Single-Use
This cleanroom microbial monitor is an innovative replacement for settle plates, provides 2 hr sampling, and minimizes false positives, resulting in a decrease in investigations.
Cleanroom Particle Counter: Lasair® III
Cleanroom particle counter sets the standard for cleanroom particle counters and meets the requirements of ISO 14644-1:2015 and ISO 21501-4.
Facility Monitoring System (FMS): FacilityPro®
Facility Monitoring System with industrial control assures data integrity, process automation, simplicity of use, and data integration.
