Annex 1 – Einblicke & Updates
Die Europäische Kommission hat ihren Annex Entwurf zur Überprüfung und Kommentierung freigegeben. Unsere Experten haben dieses Dokument sorgfältig geprüft und ihre Erkenntnisse mit Ihnen geteilt.
Hier sind einige kurze Videoausschnitte zu einzelnen Themen, die in Annex 1 Rev. 12 behandelt werden:
- Annex 1 2020 Update: Continuous Viable Monitoring
- Annex 1 2020 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)
- Science v. Standardization: Meeting auditor’s expectations by understanding the reasoning behind the rules
- Using a Risk Assessment to set microbiological plate incubation conditions
- Microbiological Plate Incubation
- Data Trending-Alert/Action Level Settings
Bleiben Sie auf dem Laufenden, um weitere Informationen zu erhalten, oder erhalten Sie eine Zusammenfassung des Überarbeitungsentwurfs des EU-GMP-Annex 1, indem Sie das folgende Papier lesen oder das On-Demand-Webinar rechts ansehen. Wir haben auch FAQs mit Antworten unten. Scrollen Sie auch nach unten, um einige unserer GMP-kompatiblen Produkte anzuzeigen.
Annex 1 Einblicke: Wissen / Dokumente
Privat: EU Annex 1:Impact on Environmental Monitoring for Clean Manufacturing
On December 20th, the first draft for a Revision of EU ANNEX 1 was published for public comment. Particle Measuring Systems put together a team of industry experts to provide their insights of the new aspects of environmental monitoring in sterile manufacturing and its probably implications to Pharmaceutical manufacturers.
Privat: 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.
Privat: 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?
Mit Anhang 1 des EU-GMP-Leitfadens konforme Produkte
Microbial Monitor: BioCapt® Single-Use
This cleanroom microbial monitor is an innovative replacement for settle plates. In combination with an active air sampler, it provides Annex 1 compliant 2-hour sampling, and minimizes false positives, resulting in a decrease in investigations.
Cleanroom Particle Counter: Lasair® III
Robust and reliable cleanroom particle counter meets the requirements of ISO 14644-1:2015, EU GMP Annex 1 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.
