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 […]
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.
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 […]
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 […]
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 […]
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 […]
In this blog series we will examine what a new fill line looks like with and without QbD implemented at the design phase. We will study each critical area of the fill line and the activities necessary to effectively bring the control features into effect. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.
Science vs standardization: justification vs blindly following rules. The new auditors’ expectations for a cleanroom monitoring plan Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 draft frequently uses the terms “risk” “justify” and “strategy”, […]
The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing. Here we highlight requirements related to Quality Risk Management that are specifically […]
L’ultima bozza dell’ Annex 1 offre diverse anticipazioni aggiornate sulla pulizia, la decontaminazione e la disinfezione. Definizioni (come dal ‘Glossario’) Pulizia (NUOVO – termine/definizione aggiunta nella rev 12): Processo per la rimozione della contaminazioni, ad es. residui di prodotto e residui di disinfettanti. Decontaminazione Il processo complessivo di rimozione o riduzione di eventuali contaminanti (chimici, […]