Bilcare Global Clinical Supplies Project Management Team

QP Services

Bilcare offers QP Services in accordance with the EU requirement that all investigational, medicinal products manufactured or imported by organizations holding a MA IMP have available a Qualified Person to approve and release each batch of IMP for clinical trial use.

The Bilcare QP Services Team

Scope of Work

The Bilcare QP Team has expertise in a wide range of areas including:

Audit of manufacturing sites within and outside the EU;
Assessment of each batch for 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, the order, protocol and randomization code.
Production conditions;
The validation status of facilities, processes and methods;
Examination of finished packs;
Where relevant, the results of any analyses or tests performed after importation;
Stability reports;
The source and verification of conditions of storage and shipment;
Audit reports concerning the quality system of the manufacturer;
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;
Where relevant, regulatory requirements for marketing authorization, GMP standards applicable and any official verification of GMP compliance;
All other factors of which the QP is aware that are relevant to the quality of the batch;
Physical examination of packaging.

Global QP Services Capabilities