Aseptic services

Supply of aseptically Prepared Doses of IMPs Across Legal Boundaries Version 2 October 2019

11 November 2019This document has been developed by the NHS Quality Assurance Committee and National Pharmacy Clinical Trials Advisory Group with input provided by the MHRA Clinical…

Repacking and over-labelling small batches of medicines

1 October 2020Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP

Content page for Yellow Cover Documents (Yellow Cover)

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

Guidance on Definition of Supervision under Section 10 Aseptic Preparation Activities, 3rd Edition, Sep 2019 (Yellow Cover)

3 September 2019The NHS Aseptic Services Accreditation Working Group, working closely with the South West Product Approval Accreditation Programme have developed and published a definition of Supervision…

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…

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…

Trastuzumab: informing intrathecal risk assessment

11 August 2022Trastuzumab products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Thiotepa: informing intrathecal risk assessment

11 August 2022Thiotepa products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Topotecan: informing intrathecal risk assessment

11 August 2022Topotecan products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Hydrocortisone: informing intrathecal risk assessment

11 August 2022Hydrocortisone products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

SPS - Specialist Pharmacy Service

NHS