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Purée in a blender, or push through a food mill for a smooth consistency. Turn off the heat, tear the bread into little pieces and soak it in the milk until it partially dissolves.

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A key part of planning for a clinical trial is ensuring that the IMP is of sufficient quality and quantity for both the start of the study and for the full duration of the study.

It is not unusual for a study to be substantially delayed because the IMP is not available.

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taste, texture, colour, film-coating, hardness, primary packaging) IMP Considerations 8 ‘Imports’ from Non-EU Countries IMP manufactured outside EU: QP to verify that the IMP was manufactured to GMP standards equivalent to EU GMP QP may have to performs site audits Additional analytical testing of IMPs may be required on import to Europe QP declaration on GMP equivalence to EU GMP using the template available on the MHRA website Signed by a QP named on the manufacturer’s authorisation of the importer Should be trial and product specific Applies to placebos as well Common issues: Lack of substance behind QP declaration How does the QP know the actual site of manufacture? Transportation conditions not known The QP certified an imported IMP as free of Transmissible Spongiform Encephalopathy (TSE) but no evidence was available to support this decision.

IMP Considerations 9 Technical Agreements Set Out the Roles and Responsibilities of Each Party Common issues: Non-existent Essentially commercial in nature Agreement not in place before manufacturing commences Lack of detail concerning GMP responsibilities: Sourcing of materials QP duties Recall responsibilities Approval and supply of relevant documents Taking of samples/testing/retention No requirement for signed QP certification Refer to Appendices that do not exist IMP Considerations 10 Labels GMP Directive 2003/94/EC: Preamble 9: In order to protect the human beings involved in clinical trials and to ensure that investigational medicinal products can be traced, specific provisions on the labelling of those products are necessary.