Preparing
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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.
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.
Managing the risks of using effervescent tablets in children
11 February 2026Careful use of effervescent or soluble tablets to deliver part tablet doses for children and neonates can minimise risks of toxicity or suboptimal therapy.
Pharmacy oversight and supervision when preparing cellular ATMPs
11 February 2026This guidance provides definitions of oversight and supervision and clarifies where each are required when implementing ATMPs.
Performing preparation risk assessments for ATMPs
11 February 2026Preparation risk assessment tools for cell and tissue-based Advanced Therapy Medicinal Products (ATMPs) and in-vivo gene therapies.
Mitigating the risks of manipulating injectable medicines
10 February 2026Identified patient-safety risks associated with manipulation must be mitigated as far as reasonably possible.
Risk factors: manipulation of injectable medicines
10 February 2026Key factors to be considered when assessing potential patient-safety risks of aseptic manipulation of injections.
Assessing risks when reconstituting injectable medicines
10 February 2026Assess risks of error and contamination when choosing the appropriate location for aseptic manipulation of injectable medicines.
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)
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.