Angela Hallam SMPU Cardiff and Vale University Health Board Angela.Hallam@wales.nhs.uk. Clinical Trials and Pharmacy. Aims of Presentation. The aim of today is to provide information regarding the manufacture of Investigational Medicinal Products (IMPs).
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This is the transposed Directive 2001/20/EC.
This is the transposed Directive 2005/28/EU.
The manufacture of an IMP must take place in a unit with a licence to manufacture IMPs and must be certified to the Sponsor by a QP named on that units licence.
IMPs with a product licence have already been released on to the market by a QP. If they have an EU licence and are being used in their licensed form then a further QP certificate is not required.
If a licensed product is repacked, relabelled or manipulated then this will need to be done in a unit with a MIA(IMP) licence and a further QP certificate will be required.
NHS hospitals and health care centres can provide simple reconstitution and labelling under section 37 of the Clinical trials directive and this process does not require a QP certificate.
Copy of MIA(IMP) licence
Name of QP
Are they importing?
What are they manufacturing?What do you need to know about your manufacturer? (4)
The first stage is the ‘technical green light’ certification by the QP of the IMP to the Sponsor.
The second stage is the ‘regulatory green light’ by the Sponsor to allow the trial to commence.
A technical release is required for each IMP unless it has a MA within the EU.Technical and Regulatory Release. (2)
IMP records should document batch numbers and expiry dates.
Full traceability records of the IMP from the point of ordering, through receipt and to the point of transfer to the next health care professional should be in place.Accountability (3)
Document details of individual subject packs
Document quantities of bulk for active and placebo
Date and time of receipt of IMP from courier
Record batch numbers and expiries
Detail any problems with packaging and/or delivery conditionsAccountability (4)Receipt of IMP into Pharmacy
A good example for a pharmacy audit can be found in the ‘Guidance Document for Clinical Trial Activities’ 2009 published by NHS Pharmaceutical Quality Assurance Committee