What is Good Manufacturing Practice (GMP) for Sponsors?
As a Sponsor, you have the ultimate responsibility for ensuring product compliance, quality, safety, and efficacy. Vendor GMP compliance realisation is the responsibility of your chosen outsourced partners e.g. CMOs, storage facilities and contract testing facilities, but you, as the Sponsor, have a responsibility to facilitate and oversee that they are meeting their GMP requirements.
Sponsors are used to having GCP procedures in place to deliver the clinical trial but are less familiar with GMP and often leave it to their outsourced partners. However, in order to support GMP compliance throughout the development and manufacture of your product, there should be GMP focussed processes and procedures within your own quality system.
But where can you find guidance?
There is little in the way of direct guidance for a Sponsor GMP Quality System, and it requires interpretation of available documents such as EudraLex Volume 4 Chapter 1 and Chapter 7, ICH Q10 and EMA Reflection paper on GMP for MAHs. These guidance documents tend to focus on the development of an operational quality system, at a CMO for example, and setting out the requirements for when manufacturing products on a commercial scale. This is where JWQC can help. We have interpreted the guidance and designed elements of a GMP Quality System suitable for Sponsors, based on our experience, which can be used as a starting point and be adapted for your particular product and process.
So what does a Sponsor’s GMP Quality System look like?
Broadly speaking, the Sponsor GMP Quality System focusses on two themes, with Quality Risk Management at the heart of each:
Vendor Assessment and Control:
Is your supply chain capable of manufacturing your product in compliance with GMP?
Does your supply chain handle quality events appropriately?
How is feedback communicated and acted upon?
Product Control and Knowledge Management:
How are your technical requirements and commitments communicated and documented?
How are process improvements handled?
How are individual batches accepted?
Get in touch here to discuss how JWQC can support you in the design and implementation of an appropriate GMP Quality System to achieve your responsibilities as a Sponsor.