Virtual Quality Management
Clinical trial sponsors are legally responsible for the conduct of their trials, even if the work is sub-contracted. Regulatory authorities expect to see evidence that sub-contractors have been audited, and Technical Agreements in place, before work begins, and that the sponsor regularly monitors their work to ensure that project and regulatory objectives are being met. Companies have received GMP deficiency letters for failure to do this. Compliance can be difficult for small companies that do not have sufficient quality assurance expertise to carry out this oversight themselves, and who cannot afford the expense of employing a full-time member of staff, or for this staff member to be travelling to audits and project meetings at contractor sites.
Our Virtual Quality Management product is specifically designed to help small pharmaceutical companies comply with regulatory requirements and prevent GMP deficiencies. A dedicated quality professional works directly for you on a part-time basis; much more cost-effective than employing a full-time employee or interim manager.
Amongst the tasks carried out by this quality assurance specialist are:
- Setting up quality systems and Standard Operating Procedures
- Auditing CRO's and Investigational Medicinal Product manufacturers for compliance with GCP and GMP
- Releasing supplies
- Drawing up Technical Agreements with each contractor
- Good Manufacturing Practice documentation reviews
- Ongoing project reviews and problem solving