With the implementation of the Clinical Trial Directive 2001/20/EC in May 2004 all companies and sponsors undertaking clinical trials in the EU will have to comply with new legislation and regulatory requirements.

Investigational Medicinal Products (IMPs) which are manufactured outside the EU must be imported into a licensed facility and released by a Qualified Person (QP) upon entry to the EU. This ensures their compliance with current EU GMP guidelines. Therefore, sponsors of the clinical trials must now have access to the services of a QP, to comply with the Directive.

We're here to help

We routinely manufacture and release clinical trial supplies for multi-national clients to the same standard of GMP as required for commercial products.

Penn Pharma has a strong team of EU Qualified Persons (QP) who have extensive experience of working with worldwide clients across all dosage forms.

Our lead QP

Paul Thomas B.Sc, C.Chem, MRSC, Chief Scientific Officer and Lead QP

What is a QP?

• Is qualified in Chemistry, Pharmacy or Microbiology.
• Has extensive pharmaceutical experience.
• Is required to keep up to date with developments in quality and regulatory areas.
• Is listed in a register.
• Is named on a Manufacturers or Dealers Licence.
• Takes personal responsibility for product quality.

The role of QPs

• To facilitate the smooth transition through the regulatory process for release.
• To ensure that each batch has been manufactured in accordance with current EU GMP guidelines and with its authorisation.
• Ensure that the QP has access to relevant records if a recall is required.

Our QPs will:

• Perform a diagnostic review of the client's regulatory position.
• Produce a proposal and Technical Agreement.
• Perform a familiarisation visit to the site of manufacture if required.
• Review the appropriate regulatory authorisation and perform the release.

How must they do it?

• Annexe 13 of the GMP requirements states that QP certification must be by personal knowledge of procedures, facilities, expertise and Quality system at site.
• MHRA expects a familiarisation audit to be conducted.

Penn Pharma can import clinical trial supplies and can package and distribute as necessary. We also give advice on European labelling requirements.

Any analytical testing if required can also be performed in our laboratories.