An improved draft guidance to process validation.
The Global Harmonization Task Force has just released a new revised draft guidance on process validation. Although it contains much of the information included in the previous draft, some points have been added, and some that were confusing or not helpful have been clarified or eliminated. This article discusses the contents and usefulness of the latest draft process validation guidance document.
Donawa
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Donawa and Associates Ltd., Rome, Italy. donawa@srd.it
D004867:Equipment Design / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D013677:Medical Laboratory Science / Q000592:standards / Q000639:trends; D006113:United Kingdom