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Assuring the supply chain for IMPs and NIMPs

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Topics: Clinical trialsService advice and planning

Sponsor pharmacy role regarding the supply assurance of Investigational Medicinal Products (IMPs) and Non-Investigational Medicinal Products (NIMPs) in CTIMPs.

This article forms part of a series
  1. The role of the sponsor pharmacy in clinical trials of investigational medicinal products (CTIMPs)
    1. Understanding local governance in CTIMPs
    2. Supporting funding applications for CTIMPs
    3. Understanding essential documentation for clinical trials submissions
    4. Risk assessing Investigational Medicinal Products (IMPs)
    5. Additional considerations for single or multi-centre trials
    6. Assuring the supply chain for IMPs and NIMPs
    7. Constructing a pharmacy manual for clinical trials
    8. Feasibility and setting up of clinical trials at delivery locations
    9. Monitoring and auditing clinical trials
    10. Closing clinical trials

Contents

  1. Managing IMP and NIMP supply
  2. Vendor Assessment
  3. Quality Technical Agreements (QTAs)
  4. UK use of IMP certified in an European Economic Area (EEA) listed country
  5. Update history

Managing IMP and NIMP supply

The use of a Sponsor Pharmacy manual/Sponsor Investigational Product management document may be of use to ensure clarity of all operations being undertaken for the specified trial. This document will be updated throughout the lifespan of the trial depending on the changing landscape of the trial and alterations to the IMP and NIMP supply chain or manufacturing.

The Sponsor Pharmacist should review and agree specification for the IMP and NIMPs and any appropriate analytical testing required, when appropriate. This information would be contained in the IMPD/sIMPD and NIMPD and sNIMPD respectively.

Vendor Assessment

A vendor assessment is required where IMP and/or NIMP manufacturing, labelling and distribution are delegated to a third party.

Where the vendor assessment deems that an audit is necessary to assess the manufacturer and laboratory, this is a specialist requirement. The auditor should be competent in manufacture and quality control of product type. Depending on the level of experience/complexity of the IMP and/or NIMP, the expertise of a QP auditor should be engaged.

Quality Technical Agreements (QTAs)

QTAs must be put in place between the sponsor and the vendor to document respective responsibilities, and must include the quality standards that will be adhered to (e.g. GCP, GMP, GDP). In some cases, this may be also present as a separate section in the general contract agreement with the Sponsor.

The Sponsor Pharmacist must check the technical agreement(s) in place for the IMP and/or NIMP supplies; this includes manufacturing and distribution of IMP and/or NIMP which must be performed in accordance with Good Manufacturing Practice. The following template provides an example of a QTA for IMP manufacture. Similar principles will apply for NIMPs, though manufacture will be undertaken by the holder of a manufacturers specials (MS) licence. Note these may vary depending on the nature of the product and specific arrangements of the trial.

UK use of IMP certified in an European Economic Area (EEA) listed country

Where the IMP is manufactured in an EEA listed country there is a regulatory requirement for IMP that will be delivered to UK sites to undergo importation via a UK MIA (IMP) holder with QP oversight.

The Sponsor Pharmacist must ensure that where this is relevant to the trial, there is an appropriate MIA(IMP) holder in the UK undertaking the relevant responsibilities to ensure that the IMP is compliant with UK regulatory requirements (SPS page).

Update history

  1. Article and attachment updated in line with amendments to clinical trials regulations. Title amended.
  1. Republished
  1. Published