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A Guide to Quality Control Chemical Testing of Aseptically Prepared Products
2 July 2021
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This document covers laboratory chemical analysis of aseptically prepared products. The reasons for analysis are outlined in Section 2 of this document
A Standard Protocol for Derivation and Assessment of Stability Part 4 – Parenteral Nutrition
1 June 2017
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To support NHS compounding units and purchasers to derive and assess stability data for pharmaceutical products (Specials and extemporaneously compounded).
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.
A Standard Protocol for Deriving and Assessment of Stability Part 3 – Oral Liquid Medicines
29 February 2016
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This document is intended to cover stability testing of all oral liquid formulations including suspensions, emulsions, solutions and powders for reconstitution
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
Accredited training for pharmacy staff within technical services
17 March 2023
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Pharmacy staff involved in the preparation of aseptically-prepared products should be suitably trained and accredited to assure a safe service
Amikacin: informing intrathecal risk assessment
11 August 2022
·
Amikacin products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
Guidance
Aseptic services
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
Registration required
Azacitidine: Cytotoxic Drug Stability Monograph
1 September 2020
·
Stability information is essential for the safe aseptic preparation of azacitidine
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