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Standard Protocol for Deriving and Assessment of Stability - Part 2: Aseptic Preparations (Biopharmaceuticals)

6 March 2017Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.

A Standard Protocol for Deriving and Assessment of Stability - Part 1 Aseptic Preparation

23 January 2017This YCD applies to small molecule products of all presentations prepared by aseptic manipulation of sterile pharmaceutical products.

Risk Associated with the Outsourcing of the Aseptic Compounding of Parenteral Nutrition (Yellow Cover)

16 December 2016The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to…

Content page for Yellow Cover Documents (Yellow Cover)

22 April 2016A list of Yellow Cover Documents is provided below

A Standard Protocol for Deriving and Assessment of Stability Part 3 – Oral Liquid Medicines

29 February 2016This 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 2013This 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 2013Disposable 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 2012The purpose of this document is to advise all NHS and academic units that manufacture radiopharmaceuticals, and their auditors, on recommended minimum standards for Quality…
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