Production documentation--the requirements of the "Guide to Good Manufacturing Practice for Sterile Medical Devices and Surgical Products 1981".

Abstract

This paper discusses many of the Documentation requirements of the "Guide to Good Manufacturing Practice for Sterile Medical Devices and Surgical Products 1981", the "Blue Guide". Particular emphasis is placed on Production Documentation as far as commercial manufacturers are concerned. The author's views on the applicability of the requirements to NHS Sterile Services departments are also given.