Preparing
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Supervision of aseptic preparation under Section 10 exemption
17 November 2025The section 10 exemption from the Medicines Act permits aseptic preparation of medicines under the supervision of a pharmacist.
Repacking and over-labelling small batches of medicines
4 January 2023Smaller packs of licensed medicines can be produced for clinics and departments by their hospital pharmacy, under pharmacist supervision in accordance with GMP
Requirements for governance and preparation of gene therapy
11 February 2026Practical advice for centres implementing gene therapies detailing governance requirements and optimal preparation location decision making support.
Outsourcing ATIMP storage or preparation across legal boundaries
11 February 2026Guidance on the considerations for pharmacy clinical trial sites outsourcing activities involved in the delivery of ATIMPs.
Outsourcing marketed ATMPs: A template technical agreement
11 February 2026A template Quality Technical Agreement for outsourcing the receipt, storage, preparation and onward supply of marketed cryopreserved ATMPs.
Understanding and managing the risks associated with handling monoclonal antibodies (mAb)
29 January 2026A systematic approach to occupational risk assessment informs decisions about safe working practices with monoclonal antibodies (mAb)
Manufacturing and preparation
All our advice relating to the technical and practical preparation of medicines.
Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS
12 April 2022National guidance from NHSE/I to reduce LASA errors and improve patient safety when considering requirements for unlicensed specials medicines
Occupational exposure to monoclonal antibodies
22 October 2025Understanding potential exposure to monoclonal antibodies (mAb) informs the occupational risk assessment
Safe handling of monoclonal antibodies
27 June 2025Considerations for occupational safety when preparing monoclonal antibodies (mAb)