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Standard Protocol for Deriving and Assessment of Stability - Part 5 Sterile Products

1 June 2017This protocol applies to small molecule products of all presentations, manufactured from non-sterile starting materials and sterilised in their final container.

A Standard Protocol for Derivation and Assessment of Stability Part 4 – Parenteral Nutrition

1 June 2017To support NHS compounding units and purchasers to derive and assess stability data for pharmaceutical products (Specials and extemporaneously compounded).

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…
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