GMP, CSV, FDA, SOP – We Love Acronyms, But What Do They All Mean?

Here’s a little guide to acronyms you’ll run into on this blog, and throughout the pharm, biotech, and med devices industries. Here’s some of my favorites:

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CSV – Time for Computer System Validation!

CSV can seem scary – but it doesn’t have to be!

URS for Purified Water Systems

WFI Still

Hello good people of the world! Today’s post deals with the User Requirements Specification (URS) for a Purified Water System. It may be RO/DI, Purified Water, or WFI, but it should probably have a URS. As with any URS, make sure requirements are specific, measurable, accurate, repeatable, and testable. Considerations specific to purified water systems include:

Creating a User Requirements Specification (URS)

Life without a good URS

Purpose of a URS:

• Specify guiding regulations and industry and site standards the system must meet
• Specify deliverables

Tips:

1. Ensure each requirement has a unique number. This is for ease of traceability and referencing in other documents
2. Evaluate the impact to quality in the URS itself. This will allow agreement up front for what requirements will need to be tested as part of qualification/validation, and which can be safety ignored.
3. Each requirement should be specific and measureable so that it can be easily tested. While it’s tempting to include statements like “The XYZ system shall comply with applicable regulations” this statement really becomes meaningless because it is not specific enough, and is not testable.