1 October 2020 · Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP
29 July 2013 · This document is based on the North West Guidance Document on Computer Systems Validation. The Orange Guide 2002 Annex 11 introduced a requirement for validation…
20 December 2018 · This test protocol is supplementary to Quality Assurance of Aseptic Preparation
Services, Fifth edition, Edited by Alison M Beaney, Pharmaceutical Press, 2016.
29 July 2013 · Disposable syringes are regularly used as final containers for aseptic products prepared within hospital units. This protocol is intended to describe standardised and validated methods…
24 May 2010 · This document is intended to provide a framework for NHS Pharmaceutical Quality Control laboratories to enable a consistent and robust approach to analytical method validation.…
25 May 2010 · The Validation Master Plan (VMP) is a summary of the planned validation activities. It lists those activities and essential documents which will be generated and…
17 April 2012 · The purpose of this document is to advise all NHS and academic units that manufacture radiopharmaceuticals, and their auditors, on recommended minimum standards for Quality…
31 July 2015 · Following a series of patient deaths in 2014 linked with Bacillus cereus infections (MHRA, 2014) and observations of practice and microbiological monitoring made during…