Tag: advisory services

NewsData Analytics in Pharmaceutical Manufacturing

Data Analytics in Pharmaceutical Manufacturing

What Cleanroom Data Analytics in Pharmaceutical Manufacturing Should be Considered When Setting up Environmental Monitoring? Pharmaceutical Manufacturing Data Analytics and Managment is one of the important steps for effective contamination control In a typical pharmaceutical manufacturing plant, there are several important tasks to ensure the product can be handled without…

NewsAirflow Visualization best particle counter ISO cleanroom standards

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…

NewsQuality by Design QbD

Consideration and Steps for Building a Contamination Control Strategy (CCS) – Series Part 3 of 4

How to define a Contamination Control Strategy (CCS) in 3 steps.
Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This blog series goes into depth on both topics.

NewsMicroplastics in Wastewater

Consideration and Steps for Building a Contamination Control Strategy (CCS) – Series Part 2 of 4

How do the guidelines define a Contamination Control Strategy (CCS)?
Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This blog series goes into depth on both topics.

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