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Aseptic services
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Diamorphine hydrochloride products: information for supporting intrathecal risk assessment
11 August 2022
·
Diamorphine products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
Standard Protocol for Deriving and Assessment of Stability - Part 2: Aseptic Preparations (Biopharmaceuticals)
6 March 2017
·
Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.
About SPS Cytotoxic Drug and Biopharmaceutical Stability monographs and advice
24 August 2020
·
Validated 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 2021
·
Originally published in 2010, information in this yellow cover document remains useful
A Standard Protocol for Deriving and Assessment of Stability - Part 1 Aseptic Preparation
23 January 2017
·
This YCD applies to small molecule products of all presentations prepared by aseptic manipulation of sterile pharmaceutical products.
Choosing an injectable medicine for intrathecal administration
11 August 2022
·
The intrathecal route is a high risk route of administration. It is essential to consider the properties of the medicinal product when assessing the risk
Assurance of aseptic preparation of medicines
13 January 2023
·
Updated guidance from NHSE to reflect governance and visibility of the assurance and audit of unlicensed aseptic preparation
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.…
Temperature controlled storage of medicines
22 March 2024
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