Quality Resource – Product Validation Protocol Template (MS Word)
Posted by Diane Kulisek on October 5, 2009
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Anyway, let’s talk about this particular resource. As I began working in FDA-regulated companies, I realized that there was a need to structure the means by which new or changed products were ‘validated’. Just so we’re clear, ‘validation’ means checking to be sure what you’ve got is appropriate for an intended use. Validation is typically structured against the Product Specification, which will be used to drive labelling and product performance claims. There are many ways to approach validation and each is uniquely tailored to a specific need… but I thought you might like to see a somewhat standard and simple format for a product validation protocol that has worked for me. Feel free to use it as a template for your own validation efforts.
If this particular validation approach doesn’t seem to resonate well with your specific needs, try searching Google for others. I got 474 MS Word document hits when I entered this search string: “validation protocol” filetype:doc .
As always, if you need a particular form or advice on any other quality-related matter, feel free to contact me.