Data Trending and Alert/Action Levels definition are new requirements in the latest EU GMP Annex 1, Revision 12 draft. Trends allow you to quickly and easily identify changes in your cleanroom data and leverage this to make effective decisions, changes, and adjustments often before problems occur. Here we discuss three key components in the latest […]
Monitoraggio Microbiologico Continuo dell’Aria secondo l’Annex 1 Draft, Rev 12
Il monitoraggio microbiologico continuo dell’aria è ora una considerazione, ovvero una raccomandazione, delle nuove sezioni dell’Annex 1 draft, rev. 12. In questo articolo esamino tale indicazione nonché i requisiti generali di monitoraggio ambientale, uno degli argomenti della nuova serie di articoli di Particle Measuring Systems sulla nuova bozza dell’Annex 1. Scoprite cosa richiede l’Annex 1 […]
High Flowrate Monitoring Uses and Benefits
Sampling standards keep managers of environmental monitoring (EM) on their toes. Read this blog to learn more about how to use high flowrate monitoring to make the most out of your EM practices in less time.
The New Normal & Data Integrity eSignatures
Imagine a world where giving an getting approvals was easy for all to accomplish and equally easy to track and access. Such a world would work very well in the “new normal” when employees are frequently remote and unavailable for paper signatures. With Particle Measuring Systems’ PharmaIntegrity data management system you get a 21CFR11 compliant […]
Audit a distanza nel Mondo della Nuova Normalità
Il Covid-19 ha portato la necessità di anticipare ad oggi il modo di lavorare di domani. Questa “nuova normalità” significa che molte persone lavoreranno a distanza il più spesso possibile. Questo presenta delle sfide, tra cui il modo di condurre un audit. Fortunatamente, c’è una soluzione disponibile oggi per risolvere questa “nuova normalità” quando si […]
Soluzioni per Cleanroom che supportano il lavoro agile nella Nuova Normalità: Parte 1
Accesso Remoto ai dati di Monitoraggio Particellare, Firme Elettroniche 21CFR11 … La Nuova Normalità è qui. Le aziende vogliono proteggere i loro dipendenti, mantenere in funzione la produzione farmaceutica, lavorando in modo efficiente ed efficace e portando il prodotto sul mercato in modo sicuro e veloce. Questo presenta una vasta gamma di sfide che non […]
Microbiological Plate Incubation and Pharmaceutical Risk Assessment
The new EU GMP Annex 1 draft, Rev 12 specifies the requirements of a pharmaceutical risk assessment to set appropriate microbiological plate conditions. This blog discusses this requirements to use a risk assessment, and then provides an interpretation on how to apply it and use it in different stages of the manufacturing process. There are […]
Cleanroom Monitoring System per Annex 1 draft
Cleanroom Classification v. Cleanroom Qualification v. Cleanroom Monitoring Per EU GMP Annex 1, rev 12 draft Part 3 of 3 part blog There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here: The goal of a cleanroom monitoring system is to assess the potential contamination risk of the product. The key […]
Cleanroom Classification
Part 1 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The latest Annex 1 draft has some new definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring. Cleanroom Classification Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015 which […]
Cleanroom Process Risk Assessment per Annex 1
In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one. Process Risk Assessment: Why it’s important A process risk assessment helps you to to ensure risks are properly […]
