The new EU GMP Annex 1 – Environmental Monitoring Sampling Zones

by: Ana Franco Matamala – CQV Operations Manager @ PQE Group

How to determine, using a risk-based approach, the number and position of sampling zones in environmental monitoring

More than two years have passed since the publication of the new version draft of Annex 1 EU GMP vol. 4. We all agree that this new revision provides significantly more detailed requirements regarding sterile manufacturing.

One of the most challenging issues is the new approach to Environmental Monitoring (EM) of our facilities, based on a Risk Management strategy. The new draft requires us to define and optimize all the parameters that compose the monitoring plan; one of the new requirements is to define the exact location and the number of sampling points needed to perform a correct EM, always under the perspective of the risk-based approach.

For this purpose, we must be able to answer this question in an objective way: why are the EM sampling points placed in that exact location? In order to be able to answer this, we must carry out a study based on a risk analysis that determines what would be the correct position of the sampling points, depending on the movement of particles within our rooms.

This study must consider all the necessary inputs and which of these may represent a possible source of contamination. We will evaluate numerous details, including the design of the facilities, the design of the room itself, the operations inside the work area, the personnel and material and how personnel moves within the work area, , air leaks between rooms, etc.. We will put all of this together and, after evaluating the criticality of each one of these parameters, we will consider which areas present the greatest movement of particles and, therefore, the possible sampling points.

In conclusion, the critical sampling points that we will carry out for the Environmental Monitoring will be all those which, due to the design of the installation, such as the personnel and  material flow / operations / operators’ work / air exchange between rooms etc., present a potential risk for the quality of the product and, consequently, for the patient’s safety.

 

 

 

Any issue with sterile manufacturing?

PQE Group staff comprises experienced and skilled experts that can support you in the goal for compliance in every aspect of your aseptic manufacturing: sterility assurance strategies, quality compliance, microbial monitoring, cleanroom design and revamping, equipment qualification, critical system validation, analytical methods selection and validation, and many others.

Visit our Qualification services page or contact us to find the most suitable solution for your company.

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