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 […]
Continuous Viable Air Monitoring per Annex 1 Draft, Rev 12
Continuous viable air monitoring is now a consideration, or even a recommendation in the new sections of Annex 1 draft, rev 12. Here I discuss this as well as the overall environmental monitoring requirements as part of Particle Measuring System’s series on the newest Annex 1 draft. Learn what Annex 1 is saying it will […]
Audits à distance dans cette nouvelle normalité
Covid-19 a amené le besoin de la manière de travailler de demain nous écraser aujourd’hui. Cette «nouvelle normalité» signifie que de nombreuses personnes travailleront à distance aussi souvent que possible. Cela présente des défis, y compris la façon de mener un audit. Heureusement, il existe une solution disponible aujourd’hui pour résoudre ce problème «nouveau normal» […]
Particle Counter Data and Cleanroom Solutions in the New Normal: Part 1
Particle Counter Data Remote Access, 21CFR11 Electronic Signatures…. The new normal is here. Companies want to protect their employees, keep pharmaceutical manufacturing running, while working efficiently and effectively and getting product to market safely and quickly. This presents a wide range of challenges that we did not face at the beginning of 2020. Fortunately, Particle […]
Incubation sur plaque microbiologique et évaluation des risques pharmaceutiques
Le nouveau projet de l’annexe 1 des BPF de l’UE, Rev 12, spécifie les exigences d’une évaluation des risques pharmaceutiques pour définir les conditions microbiologiques appropriées des plaques. Ce blog traite de ces exigences pour utiliser une évaluation des risques, puis fournit une interprétation sur la façon de l’appliquer et de l’utiliser à différentes étapes […]
Stratégie de Contrôle de la Contamination et Annexe 1
Science vs standardisation: faut-il justifier ou suivre les règles a l’aveuglette. Les attentes des nouveaux auditeurs L’annexe 1 exige la conception d’une stratégie efficace de contrôle de la contamination (CSC) basée sur une évaluation scientifique pour comprendre le processus et appliquer les principes de gestion des risques. Le dernier projet d’annexe 1 utilise fréquemment les […]
Cleanroom Qualification
Part 2 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification. Qualification methodologies […]
Comment atteindre la qualité par la conception dans une nouvelle ligne de remplissage pharmaceutique: configuration et traitement des interventions (partie 4 de série 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.
Cleanroom Cleaning & Disinfection Per Annex 1, rev 12
The latest Annex 1 draft offers several updated expectations on cleanroom cleaning, decontamination and disinfection. Learn about these expectations and addressing them with a contamination control strategy (CCS) Definitions Cleaning (NEW)A process for removing contamination e.g. product residues and disinfectant residues from a cleanroom. Decontamination The overall process of removal or reduction of any contaminants […]
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.
