Process validation: harmonizing the requirements.
Medical device manufacturers marketing in Europe and the United States are faced with differing expectations regarding the quality system requirements for process validation. However, this may change as a result of a process validation guidance document being developed by the Global Harmonization Task Force. This article will discuss the document's current status, some of its elements and some suggested modifications.
Donawa
M E
ME
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D011358:Product Surveillance, Postmarketing; D014481:United States