16 December 2016 · The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to…
29 February 2016 · This document is intended to cover stability testing of all oral liquid formulations including suspensions, emulsions, solutions and powders for reconstitution
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…
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…
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…
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…
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…
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.…