Almac

As required by the Clinical Trial Directive 2001/20/EC and Annex 13 to the European GMP Guide, all Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a Clinical Trial.  A QP is required to have qualifications in Chemistry, Pharmacy or Microbiology and have wide ranging technical knowledge & experience within the pharmaceutical industry.  Each QP named on the Manufacturer’s / Importer’s License takes personal responsibility for the quality of the IMP being released.

We have a full complement of QPs and an experienced support team who are able to assist clients in the release of IMPs for use in Clinical Trials, including importation of these into the EU when necessary. Our QPs are widely known and respected within the industry and have experience across a wide range of product types and dosage forms.

This efficient service is achieved by:

• Easy to follow release procedures which provide a consistent, structured approach.
• Keeping up to date with current regulatory guidance and expectations and proactively ensuring continued compliance by advising customers of the requirements.
• Global auditing of third party manufacturing, testing, packaging and labelling facilities as required in support of QP declarations for import into the EU.
• Import testing can be supported by our Science Business Unit if required.

Information relating to the applicable European Directives, Good Manufacturing Practice and requirements for Clinical Trials are available within Eudralex Volumes 1, 4 and 10 respectively.

Click here to download a free copy of our EU Directive guide