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Preparing

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Preparing Comirnaty 3 (THREE) (JN.1) concentrate vaccine

10 September 2024An example SOP for preparing Comirnaty 3 (THREE) (JN.1) concentrate vaccine

Preparing Comirnaty 10 (JN.1) ready to use vaccine

10 September 2024An example SOP for preparing Comirnaty 10 (JN.1) ready to use vaccine

Standard Protocol for Deriving and Assessment of Stability - Part 2: Aseptic Preparations (Biopharmaceuticals)

6 March 2017Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.

Guidance Handling of Monoclonal Antibody (mAb) and Products (Yellow Cover)

16 December 2016Variation in practice underlined the need for an evidence-based guideline for handling mAbs that was suited to all those providing care to NHS patients.

Pharmacy Oversight and Supervision Requirements for Preparation of Licensed ATMPs

31 January 2020This guidance provides definitions of oversight and supervision it clarifies where each are required when implementing ATMPs.

Choosing between oral vancomycin options

18 May 2021Local decision makers should choose between the options for giving vancomycin orally. Licensing status and other factors affect decision making.

Choosing between oral fidaxomicin options

20 October 2021Local decision makers should choose between the options for giving fidaxomicin orally. Licensing status and other factors affect decision making.

A Standard Protocol for Deriving and Assessment of Stability - Part 1 Aseptic Preparation

23 January 2017This YCD applies to small molecule products of all presentations prepared by aseptic manipulation of sterile pharmaceutical products.

Preparing eye drops in unlicensed aseptic units

17 October 2023Circumstances and potential risks should be considered before preparing eye drops in NHS aseptic units working under Section 10 exemption.

How to perform preparation risk assessments for ATMPs

10 April 2024Preparation risk assessment tools for cell and tissue-based Advanced Therapy Medicinal Products (ATMPs) and in-vivo Gene Therapies.
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