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Dealing with out of specification (OOS) results: Part 2
9 May 2023
·
This webinar builds on the principles described in Part 1 of this series and describes how to conduct a thorough and systematic microbiological investigation.
Management review and KPIs in pharmacy technical services
10 April 2024
·
An SPS Quality Assurance (QA) bite size learning event on quality management review and key performance indicators (KPIs) in pharmacy technical services.
Quality Assurance and Technical Services (QATS) Symposium 2024
16 April 2024
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Bringing together NHS experts and regulators covering topics of quality assurance, quality control, good manufacturing practice and regulatory expectations.
Standard Protocol for Deriving and Assessment of Stability - Part 2: Aseptic Preparations (Biopharmaceuticals)
6 March 2017
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Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.
Registration required
Daunorubicin: Cytotoxic Drug Stability Monograph
13 November 2020
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Stability information is essential for the safe aseptic preparation of daunorubicin
Registration required
Irinotecan: Cytotoxic Drug Stability Monograph
13 November 2020
·
Stability information is essential for the safe aseptic preparation of irinotecan
Registration required
Summary of biopharmaceutical stability data reviewed and available extended shelf-life data
4 June 2021
·
The stability of several aseptically compounded ready to administer presentations of monoclonal antibody products and other biopharmaceuticals is presented.
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
Design, Build and Maintenance of Pharmacy Aseptic Units (Yellow Cover)
3 November 2021
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Originally published in 2010, information in this yellow cover document remains useful
Microbiological Protocol for the Integrity Testing of Syringes, 2nd Edition, April 2013 (Yellow Cover)
29 July 2013
·
Disposable syringes are regularly used as final containers for aseptic products prepared within hospital units. This protocol is intended to describe standardised and validated methods…
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