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 per Annex 1 draft
Part 3 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here: The goal of cleanroom monitoring is to assess the potential contamination risk of the product. […]
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 […]
Quality Risk Management Principles in Annex 1, Section 2
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 […]
Pulizia e disinfezione: le (più recenti) linee guida dell’Annex 1, rev 12
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, […]
How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)
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.
Quality Risk Management in Annex 1; 6.1
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. In part 2 of our five part series, we highlight requirements related […]
Selecting the Best Particle Counter for Your Needs (Series Part 1 of 4)
In this blog series, we take a look at common terms and initial considerations for selecting an aerosol particle monitor for various applications.
