Investigational Medicinal Products (IMPs) are among the most tightly regulated materials in the clinical research environment.
Whether you are storing a novel biologic ahead of a first-in-human study, a controlled substance under a phase II protocol, or a viral vector being evaluated in a gene therapy trial, the storage conditions and the facility holding those materials must meet a specific set of regulatory requirements.
For sponsors running studies in the UK: whether as a UK organisation or an international company working with a UK CRO: understanding those requirements upfront, and selecting a storage provider that meets them, is one of the simpler ways to protect your programme from a preventable regulatory issue.
Under UK clinical trials legislation (derived from the EU Clinical Trials Directive and Regulation, now adapted into UK law post-Brexit), an IMP is any pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. This includes active substances under investigation, comparator products, and placebos.
IMP storage is regulated because sample integrity is directly linked to participant safety and data validity. A temperature excursion, a chain-of-custody gap, or a mislabelled vial can compromise both. Regulatory bodies including the MHRA expect that IMPs are stored under conditions specified in the clinical trial protocol and the IMP dossier, and that storage facilities can demonstrate compliance through documentation.
Good Distribution Practice (GDP)
GDP is the quality framework that governs the distribution and storage of medicinal products, including IMPs. It covers temperature control, transportation, documentation, and quality management systems. A facility operating to GDP standards maintains validated processes and records that demonstrate the integrity of materials throughout the storage period.
Good Manufacturing Practice (GMP)
GMP applies to the manufacture and handling of medicinal products, and is relevant to IMP storage facilities that also handle product preparation, labelling, or packaging activities. Operating to GMP standards requires documented quality systems, equipment qualification, and batch record-keeping.
Home Office controlled drugs licence
If the IMP falls under Schedule 1, 2, or 3 of the UK Misuse of Drugs Regulations: which includes a range of substances used in pain management, anaesthesia, psychiatry, and neurological research: the storage facility must hold a Home Office licence to possess and store those substances. This is a separate and additional requirement to GMP/GDP.
Human Tissue Authority (HTA) licence
Where an IMP involves or is derived from human biological material: including cell therapies, gene therapies using human vectors, or biological reference standards derived from human tissue: the storage facility must operate under an HTA licence. This licence governs the ethical and legal use of human tissue and is a prerequisite for any facility handling such materials for research purposes.
Biosafety level approvals
Where an IMP involves viral vectors, live attenuated organisms, or other biological materials classified at biosafety level 3, the facility must be approved for the appropriate containment level. BSL-3 storage is a specialist capability and is not offered by all providers.
GCLP and GCP compliance for clinical trial support
Where stored materials are directly linked to a clinical trial: samples collected from participants, reference standards used in analysis, or IMPs awaiting dispensing: the facility's processes should comply with Good Clinical Laboratory Practice (GCLP) and Good Clinical Practice (GCP) standards, ensuring data integrity and regulatory acceptability.
hVIVO's cryostorage facility in Greenwich is HTA licensed and Home Office controlled drugs licensed, and approved for GMO and BSL-3 biological material storage. The facility operates to GMP, GDP and GCLP standards, with 24/7 temperature monitoring and response backed by uninterrupted backup power.
The facility is supported by hVIVO's broader laboratory accreditations, which include CAP accreditation (College of American Pathologists), UKAS ISO/IEC 17025:2017 accreditation, and compliance with GCP and GCLP: all validated to FDA, EMA, and ICH guidelines. See the full laboratory accreditations page for detail.
For sponsors requiring integrated support: IMP storage alongside sample processing, kit production, or analytical laboratory services: hVIVO's end-to-end biobanking capability means all of these functions can be managed under a single quality system, with a single point of contact.
Can hVIVO store controlled drugs under a Home Office licence?
Yes. The Greenwich facility holds a Home Office controlled drugs licence, meaning it can store scheduled substances that are subject to the UK Misuse of Drugs Regulations.
Does hVIVO hold an HTA licence for human biological samples?
Yes. hVIVO is accredited by the Human Tissue Authority and can provide HTA DI coverage for study collections where your organisation does not hold its own licence. See our human biological samples page for more information.
What temperature storage options are available?
hVIVO offers ambient, refrigerated (+2°C to +8°C), ultra-low (-80°C), and liquid nitrogen cryogenic storage. See the full range of cryostorage capabilities.
Can hVIVO store materials at biosafety level 3?
Yes. The Greenwich facility is approved for BSL-3 pathogen and biological material storage, and the adjacent CL3 laboratories can thaw and manipulate those materials where required.
Can IMP storage be integrated with laboratory analysis?
Yes. hVIVO's storage, sample processing, and laboratory services are fully integrated under a single quality system. This enables seamless transfer of materials between storage and analysis without the chain-of-custody risk associated with using separate providers. Contact us to discuss your requirements