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Repacking and over-labelling small batches of medicines

1 October 2020Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP

Guidance on Definition of Supervision under Section 10 Aseptic Preparation Activities, 3rd Edition, Sep 2019 (Yellow Cover)

3 September 2019The NHS Aseptic Services Accreditation Working Group, working closely with the South West Product Approval Accreditation Programme have developed and published a definition of Supervision…

A Standard Protocol for Deriving and Assessment of Stability Part 3 – Oral Liquid Medicines

29 February 2016This document is intended to cover stability testing of all oral liquid formulations including suspensions, emulsions, solutions and powders for reconstitution

Requirements for Governance and Preparation of Gene Therapy

6 February 2024Practical advice for centres implementing Gene Therapies detailing Governance requirements and optimal preparation location decision making support.

Preparing Comirnaty 30 micrograms (JN.1) vaccine

10 September 2024An example SOP for preparing Comirnaty 30 micrograms (JN.1) vaccine

Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS

1 March 2022National guidance from NHSE/I to reduce LASA errors and improve patient safety when considering requirements for unlicensed specials medicines

Standard Protocol for Deriving and Assessment of Stability - Part 5 Sterile Products

1 June 2017This protocol applies to small molecule products of all presentations, manufactured from non-sterile starting materials and sterilised in their final container.

A Standard Protocol for Derivation and Assessment of Stability Part 4 – Parenteral Nutrition

1 June 2017To support NHS compounding units and purchasers to derive and assess stability data for pharmaceutical products (Specials and extemporaneously compounded).

Manufacturing and preparation

All our advice relating to the technical and practical preparation of medicines.

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

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