In this blog post, Jelle, our Territory Account Manager - Benelux Region, looks at the importance of the URS for a pharma cleanroom project (GMP) to achieve its best potential.
As we know, the GMP guidelines form an EU directorate, meaning if it applies to the products you are manufacturing, it must be followed.
Annex 1 is often cited by cleanroom companies, as in terms of cleanroom construction the guidelines can be quite prescriptive - such as the use of “smooth, impervious and unbroken [surfaces] in order to minimize the shedding or accumulation of particles.” (EU-GMP Annex 1)
However, it is EU-GMP Annex 15 that details the importance of creating a user requirements specification, which is a key factor for successful cleanroom project delivery.
User Requirements Specification (URS)
“The specification for equipment, facilities, utilities or systems should be defined in a URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle.” (EU-GMP Annex 15)
A URS is the best starting point of any project and should define the requirements that fulfil the demands of the process. Your process, workflow and Standard Operating Procedures (SOPs) will dictate the layout of your cleanroom and being aware of all activities will reduce the number of design iterations required, if as much information as possible is detailed at an early stage.
A URS can vary from 10 pages to 50 pages, depending on size and complexity of the cleanroom area and its workflow. Creating a URS is something we can support with, as we specialise in process-built contamination control solutions.
We’d love to talk to you about where we can support your specific cleanroom requirements. Contact us, to start discussing your project today!
Thanks for reading,