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”, […]
Archives for abril 2020
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.
The new EU GMP Annex 1 rev 12 states, regarding single use systems: Chapter 8 . Production and Specific Technologies Paragraph : Single use systems (SUS) Annex 1 rev Dec 2017 – (8.117): Single use systems (SUS) are those technologies used in manufacture of sterile medicinal products which are designed to replace reusable equipment. SUS […]