Bilcare GCS offers Qualified Person services in accordance with the EU requirement that all investigational and medicinal products manufactured or imported by organizations holding an MA IMP, have a Qualified Person to approve and release each batch of IMP for usage in clinical trials.
- EU-GMP audit of manufacturing and API sites outside the EU.
- Assessment of each batch for GMP or Batch certification prior to release. May include, as appropriate:
- Batch records, including control reports.
- In-process test reports and release reports demonstrating compliance with the product specification file, protocol and randomization code.
- Validation status of facilities, processes and methods.
- Examination of finished packs.
- Audit of the results of any analyses or tests performed after import.
- Stability reports.
- Source and verification of conditions of storage and shipment.
- Documents certifying that the manufacturer is authorized to manufacture Investigational Medicinal Products or comparators for export by the appropriate authorities in the country of export.
- Regulatory requirements for marketing authorization, applicable GMP standards and any official verification of GMP compliance.
- Provision of regulatory guidance in all areas of IMPs.
- Assistance with creating Product Specification Files/Investigational Medicinal Product Dossier.
- Assistance with obtaining site GMP certification.
Qualified Persons are assigned projects according to their specialized expertise and have personal and legal responsibility as described in the EU Clinical Trial Directive (2001/20/EC). This ensures the investigational products are manufactured in accordance with EU GMP and the clinical trial authority.