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IMP Manufacture & Release

The Chief Investigator is responsible for sourcing IMP (and placebo where relevant); the sponsor is responsible for authorising the regulatory release of IMP supplies to sites.

It is essential that the Chief Investigator obtains advice and support from those with specialist knowledge relating to IMP manufacture and supply to ensure that all regulatory requirements are met.

Noclor does not have an in-house clinical trial pharmacy team so outsource (delegate out)  this expertise to a third party  to ensure sponsor oversight for all aspects of the IMP in CTIMPs (this includes assessing and advising on risks of the proposed IMP).

Sourcing IMP

The dedicated clinical trials pharmacist/technician will advise the Chief Investigator as to which companies to source the IMP/placebo from to ensure the supplies ordered are manufactured in accordance with Good Manufacturing Practice, by a holder of a manufacturing authorisation for investigational medicinal products MIA(IMP).

Where possible, at least two quotes should be considered for the IMP manufacturing work.  The Clinical Trials Toolkit Trial Supplies has a useful checklist for manufacturing costs that may need to be considered.

All discussions/meetings/correspondence in regards to IMP procurement should be documented by the Chief Investigator in the Trial Master File (TMF).

 
Ordering IMP

Noclor (or delegated responsible person) is responsible for assessing the suitability of proposed manufacturers/suppliers of IMP prior to confirming their selection, signing off any quotes, contracts or orders.

The Chief Investigator must not sign off on IMP quotes or orders on sponsor behalf.

Responsibility for the quality of IMP is generally delegated to the MIA(IMP holder) through a technical agreement.  The technical agreement must be signed by both parties before any manufacturing tasks are undertaken.

 
Regulatory Release of IMP

The release if IMP to sites is a two-step process. As the sponsor retains legal responsibility for regulatory release of IMP Step 2 must be completed prior to Noclor (on sponsor’s behalf) issuing a study activation notice to sites.

Step 1 - QP release (technical release)

Each batch of IMP must be certified as being suitable for use prior to its release by a Qualified Person (QP) as named on the MIA(IMP) specific to the CTA application.  QP certification and responsibilities of the QP are defined in Regulations 43 of SI 2004/1031. 

For CTIMPs sponsored by a Noclor partner the manufacturer/supplier of IMP will be delegated responsible for QP release /certification through the technical agreement.

Step 2 - Regulatory Release

Technical release of IMP does not constitute regulatory release of IMP.  The sponsor is responsible for authorising the release of IMP from the manufacture/supplier to the site for use in a clinical trial when assured that the requirements of Article 9 of Directive 2001/20/EC and Regulation 13 of SI 2004/1031 have been met.

The authorisation to release IMP to site correspondence (from Noclor Sponsor Representative) should be retained in the Trial Master File (TMF).  The regulatory release authorisation is a requisite checklist item for site-specific study activation.