Preparing
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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.
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
Risk assessment of preparation of monoclonal antibodies
27 June 2025A systematic approach to occupational risk assessment informs decisions about safe working practices with monoclonal antibodies (mAb)
Supervision of aseptic preparation under Section 10 exemption
3 September 2019The section 10 exemption from the Medicines Act permits aseptic preparation of medicines under the supervision of a pharmacist.
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
Manufacturing and preparation
All our advice relating to the technical and practical preparation of medicines.
Managing the risks of using effervescent tablets in children
9 March 2023Careful use of effervescent or soluble tablets to deliver part tablet doses for children and neonates can minimise risks of toxicity or suboptimal therapy.
Safe handling of monoclonal antibodies
27 June 2025Considerations for occupational safety when preparing monoclonal antibodies (mAb)
Occupational exposure to monoclonal antibodies
27 June 2025Understanding potential exposure to monoclonal antibodies (mAb) informs the occupational risk assessment
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.