Simple Systems for Sponsor Oversight
Sponsors have the ultimate responsibility for product compliance, product quality, safety, and efficacy. Implementing a simple, effective and easy-to-follow system is all that is needed to ensure your product is fit-for-purpose and manufactured to GMP as it moves through the clinical trial phases. Incorporating organised and methodical ways of working from the outset will ensure fewer roadblocks and will mean that you can always find those important documents when you need to justify decisions made.
JWQC have consultants with a breadth of subject matter expertise, who will help you to understand where the gaps are in your system and how your system can be adapted. We have also developed a straightforward system of procedures, forms, and trackers, that provide a simple and pragmatic solution that can act as the basis of your GMP Quality System from the outset.
Guidance and Education
All too often we see procedures implemented to cover Investigational Medicinal Product in a GCP Quality Management system simply state the regulation with little information as to how the sponsor actually achieves their GMP responsibilities.
JWQC can advise on how best to evolve your system into something that will ensure you make the right decisions at the right time, in a documented format that will provide evidence for investors and regulators. We can achieve this through bespoke training sessions, through regular meetings to guide key personnel, or by completing tasks and mentoring your staff.
Building Blocks
A quality system must be logical, intuitive and remain relevant for the lifetime of your product. Organising documentation methodically will ensure that you can always trace back to those important documents that evidence your product knowledge.
Please get in touch here to start the conversation about how we can help you.
