Aseptic services

Temperature controlled storage of medicines

14 August 2024

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…

Guidance for the Validation of Pharmaceutical Quality Control Analytical Methods 1st Edition (Yellow Cover)

24 May 2010This document is intended to provide a framework for NHS Pharmaceutical Quality Control laboratories to enable a consistent and robust approach to analytical method validation.…

Validation Master Plan 1st edition (Yellow Cover)

25 May 2010The Validation Master Plan (VMP) is a summary of the planned validation activities. It lists those activities and essential documents which will be generated and…

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…

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…

About SPS Cytotoxic Drug and Biopharmaceutical Stability monographs and advice

24 August 2020Validated stability data ensures products compounded by cytotoxic reconstitution processes within aseptic units are safe for patients

Design, Build and Maintenance of Pharmacy Aseptic Units (Yellow Cover)

3 November 2021Originally published in 2010, information in this yellow cover document remains useful

Process risk assessments for a Contamination Control Strategy

19 March 2024

Corrective and preventive action in pharmacy technical services

11 June 2024

SPS - Specialist Pharmacy Service

NHS