A QP is now required under the EU Good Manufacturing Practice (GMP) regulations. CentraLabS offer the following QP services:

• GMP advice to sponsors
• Support for in-house GMP licensed activities
• Manufacture of Investigational Medicinal Product (IMP)
• Quality Control (QC)
• Batch release of product for the European Union
• Support for import of IMP from a third country
• Inspection of manufacturing/analytical facilities
• Review of appropriate documentation

Medicinal products

• Support for import of Medicinal Product (MP) from third country
• Inspection of manufacturing/analytical facilities for GMP
• Review of appropriate documentation
• Ensure that appropriate analysis has been undertaken
• Certify that all requirements of GMP and authorisations have been met

Manufacturing

CentraLabS hold an Authorisation to manufacture non-sterile solid and liquid IMPs for internal and external use, including:

• Manufacture of hot and cold IMPs
• Assembly/packaging
• Storage and handling
• Distribution
• Analytical testing (QC testing)
• Import/export
• Batch Certification/Release into the EU by the QP