Il riferimento completo per EU GMP Annex 1
La Commissione europea ha pubblicato la bozza dell’Annex 1 per la revisione e i commenti. I nostri esperti hanno esaminato con attenzione questo documento e sono pronti a condividere le loro conoscenze con voi.
Ecco alcuni brevi video su singoli argomenti trattati nell’Allegato 1 Rev 12:
- 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)
- 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
Il documento che segue o il webinar registrato a destra offrono un riepilogo delle revisioni della normativa EU GMP Annex 1 Draft. Avete domande? Chiedete ad uno dei nostri esperti che saranno pronti a rispondervi o leggete la sezione di FAQ qui sotto.
I nostri Servizi di Consulenza e Formazione sono disponibili per voi – per sostenervi in ogni passo del processo, che si tratti di questioni di non conformità, allestimento di un nuovo processo, o formazione dei dipendenti. Il nostro team dispone delle competenze e della formazione necessarie.
Annex 1 Insights: Knowledge / Papers
Privato: Commenti degli esperti di settore al EU GMP Annex 1 Revision 2017
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.
Privato: Il nuovo EU GMP Annex 1 Draft: Impatto sui programmi di monitoraggio ambientale
On December 20th, after intensive research and debates, the draft for a Revision of ANNEX 1 (“Manufacture of Sterile Medicinal Products”) of the EU Guideline for GOOD MANUFACTURING PRACTICE for drug products and drug substances was published for public comment. This updated document will set a milestone for adjustments needed within European agencies overseeing drug products regulatory applications.
Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 FAQ
Viable monitoring requirements and solutions per the latest Annex 1 draft (rev 12) are discussed here by industry experts. Watch the on-demand webinar and access FAQS here.
Privato: Siete confusi sul modo in cui le variazioni proposte dall’Annex 1 Draft potrebbero interessarvi?
Industry experts answer over 40 common questions about the new draft. If you can’t find the answer to your question, the contact information for an Annex 1 expert is included at the end of the paper.
EU GMP Annex 1 Compliant Products
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.
Contatore di Particelle Portatile Lasair® III
Definisce lo standard per i contatori di particelle per aria portatili e soddisfa i requisiti di ISO 14644-1:2015 e ISO 21501-4.
Campionatore Microbiologico per Aria MiniCapt® Mobile
L’innovativo Campionatore Microbiologico Portatile per Aria. Conforme alla norma ISO 14698:2003
PharmaIntegrity Data Integrity
Creates a complete contamination monitoring solution for pharmaceutical manufacturers.
