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Content page for Yellow Cover Documents (Yellow Cover)
22 April 2016
·
A list of Yellow Cover Documents is provided below
A Standard Protocol for Deriving and Assessment of Stability Part 3 – Oral Liquid Medicines
29 February 2016
·
This document is intended to cover stability testing of all oral liquid formulations including suspensions, emulsions, solutions and powders for reconstitution
Guidance for Aseptic Transfer Processes in the NHS: Addressing Sporicidal Issues
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…
Vial Sharing in Aseptic Services Edition 1 August 2014 (Yellow Cover)
18 August 2014
Computer Systems Validation (Yellow Cover)
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…
Microbiological Protocol for the Integrity Testing of Syringes, 2nd Edition, April 2013 (Yellow Cover)
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…
Quality Assurance of Radiopharmaceuticals Edition 4 2012 (Yellow Cover)
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…
Validation Master Plan 1st edition (Yellow Cover)
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…
Visits by Quality Assurance Personnel to Pharmaceutical Manufacturers and Wholesalers 3rd edition (Yellow Cover)
24 May 2010
Guidance for the Validation of Pharmaceutical Quality Control Analytical Methods 1st Edition (Yellow Cover)
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.…
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