Meeting European and US requirements for design and development documentation, Part II.
Part I of this series of articles provided a comparison of the European and the proposed United States (US) Food and Drug Administration (FDA) design control requirements. Since writing Part I, the US Good Manufacturing Practice (GMP) final rule has been published. This article will discuss the changes made to the design control requirements in the US final rule. It will also discuss some of the types of procedures and documentation that companies can develop to comply with the European and US design control requirements.
Donawa
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Donawa and Associates Ltd., Rome, Italy.
D004282:Documentation / Q000592:standards*; D004867:Equipment Design; D004864:Equipment and Supplies / Q000592:standards* / Q000600:supply & distribution; D005060:Europe; D006801:Humans; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration