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Archives for April 2020

April 30, 2020 06:33 AM

Potential Cleanroom Sampling Points per Annex 1 Draft (Part 4 of 5)

Written by PMS

cleanroom sampling points

In part 4 of our 5-part blog series on Annex 1 Quality Risk Management, we discuss cleanroom sampling points. Definition of potential sampling points Sample points include particle counters and microbial monitors. Identification of critical areas by HACCP analysis and process understanding Choose points within the critical areas according to defined criteria When performed this […]

April 29, 2020 07:22 AM

Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Environmental Monitoring (Series Part 5 of 6)

Written by PMS

QbD for a filling line

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.

April 28, 2020 06:22 AM

Viable Non Viable Particle Counts

Written by PMS

Viable, non viable particle counts: Environmental and Process Monitoring- Annex 1, Section 9.4 In Part 3 of our 5 part blog series, we look at Viable Non Viable (V/NV ) Particle counts regarding Environmental and Process Monitoring as found in Annex 1, Section 9.4: RA should be done to develop a comprehensive environmental monitoring program […]

April 27, 2020 03:26 PM

Contamination Control Strategy and Annex 1

Written by PMS

Gowning and contamination monitoring

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”, […]

April 23, 2020 05:24 AM

Quality Risk Management (QRM), Annex 1, Section 2

Written by PMS

Quality Risk Management QRM

In Annex 1 Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations. 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 mentioned in Annex 1, including: […]

April 22, 2020 07:12 AM

How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Set up and Process Interventions (Series Part 4 of 6)

Written by Maurizio Della Pietra

Advisory Services QbD

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.

April 22, 2020 06:49 AM

How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Set up and Process Interventions (Series Part 4 of 6)

Written by PMS

Isolabor RABS monitoring

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.

April 15, 2020 08:54 AM

Cleanroom Contamination Control in a New Pharmaceutical Fill Line: Cleaning and Disinfection (Series Part 3 of 6)

Written by PMS

Filling line considerations advisory services

Cleaning and disinfection of a pharmaceutical fill line & surrounding areas is a critical component of cleanroom contamination control. We all think we are familiar with the principles of cleaning protocols, but it is deceptively easy to get this form of control wrong without applying the standards of QbD to the new equipment and facility […]

April 9, 2020 02:30 PM

How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Surrounding Areas (Series Part 2 of 6)

Written by Maurizio Della Pietra

Quality by Design Surround Areas

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.

April 24, 2020 07:08 AM

Quality Risk Management in Annex 1; 6.1

Written by PMS

Quality Risk Management Annex 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 […]

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T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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