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PubMed · 10387619

An improved draft guidance to process validation.

M E Donawa
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Abstract

The Global Harmonization Task Force has just released a new revised draft guidance on process validation.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.

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Equipment DesignEquipment and SuppliesGuidelines as TopicHumansMedical Laboratory ScienceUnited KingdomJournal Article

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M E Donawa. 1999. An improved draft guidance to process validation.. https://pubmed.ncbi.nlm.nih.gov/10387619/

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