Quality Policy

B & C Group’s motto “Perfection is our driving force” reflects management’s conviction about the need for quality and continuous improvement. Quality is not only reflected in operating working methods, the implementation of a Quality Management System, compliance to regulatory requirements and guidelines, but also addresses long term confident Customer relationships, a safe and good working environment for B & C Group Staff, as well as personal career development.

B & C Group’s willingness to have an image of seriousness and professionalism is achieved by B & C Group‘s Management and all Staff Members assuming individually and collectively the responsibility of quality and integrity.

The following Quality Objectives are/will be integrated:

• B & C Group services the Sponsors and their Subcontractors in (pre)clinical research studies according to applicable (inter)national regulatory requirements and guidelines as relevant to B & C Group Companies, e.g.:
o Good Clinical Practice (GCP);
o Good Manufacturing Practices (GMP);
o Good Distribution Practice;
o Computer System Validation (CSV) requirements, in particular 21 Code of Federal Regulations (CFR) Part 11;
o Accord Européen relatif au Transport International des Marchandises Dangéreuses par Route (ADR);
o International Airline Transport Association (IATA) Dangerous Goods Regulations.

In addition, applicable principles of other standards/norms (e.g. ISO 9000:2000 series, Engage, Good Laboratory Practice (GLP) in case of related pre-clinical study work) are taken into account.
• B & C Group ensures that all Staff Members are regularly trained on the relevant aspects of applicable regulations, guidelines and clinical trial details to make sure that the respective clinical trial is correctly serviced. An ongoing Training Plan is implemented. For B & C Group activities, GMP is strictly adhered to and the mandatory updates/trainings are integrated.
• B & C Group commits itself to manage, verify, store under adequate environmental conditions and release Investigational Medicinal Products (IMPs) under the responsibility of a Qualified Person (as per GMP).
• During the set-up, initiation, conduct and follow-up of clinical studies, B & C Group commits itself to support the studies according to ethical principles and medical deontology. As such, B & C Group ensures not to display any confidential information from the Customers and, if applicable, to treat subjects’ personal data confidentially.
• B & C Group undertakes to regularly inform the Customer about the progress of the clinical trial and to inform them of any serious deviation/event from the Clinical Trial Protocol, the Service Agreement and pre-established Standard Operating Procedures (SOPs) and/or Work Instructions (WIs).
• Clinical trial documentation and other essential B & C Group documents will not be destroyed prior to the written agreement of the Customer.
• The Quality Assurance Services department (GXP) and the Quality Control Unit (GMP) will help to ensure that the required level of quality is in place and controlled.

B & C Group Management is committed to a quality improvement program with e.g.

• Yearly Management Review Meetings;
• Analysis of Process/Performance Key Indicators;
• Yearly Training & Team Building Meeting for all B & C Group Staff;
• Follow-up on the efficient implementation of Corrective/Preventive Action Plans;
• Systems for tracking of complaints/recalls;
• Appropriate Human Resources management compared to forecasted workload.