Is Your Product Safe and Fit For Purpose?
As the manufacturer of an Investigational Medicinal Product intended for clinical trial, this is the most fundamental question that should be addressed. But it is a more complicated question to answer than it appears. For example, if a minor update to a master batch record resulted in an erroneous change to a Critical Control Parameter, could it slip through the net? How would you notice if a mistake has been made?
Do you have clear oversight of any risk to product at each of your CMOs?
Identification of hazards, and implementation of appropriate control strategies should form part of your Sponsor Oversight Responsibilities. Proactive identification and management of risk is crucial to avoiding delays and extra costs associated with your project.
If anything goes wrong during manufacture or at any of your suppliers, JWQC have GMP expertise to help you assess the associated risk to product and draw conclusions for feedback to your CMOs, to help you achieve as smooth a journey as possible to the release of your IMP.
Our Oversight Offerings
Technical Reference File
Have you confirmed that manufacturing instructions, including any critical quality attributes have been written against your most up to date product knowledge?
Do you have permanent traceability of your decisions, applicable to any stage of your IMP manufacture?
As a Sponsor, it can be difficult to keep track of all the documents that have been generated during IMP development either by you or your CMO(s). JWQC can provide you with a simple process whereby an index of technical documents is developed, alongside the appropriate CMC expertise, for each product or range of similar products.
By identifying all the relevant technical documents in an index, this can then be easily referenced by personnel certifying your product or releasing your product to the next stage of manufacture, thus ensuring that your product requirements and regulatory commitments are met.
Proactive Risk Control
The bedrock of any quality management system should be ensuring that risks involved in the introduction of new processes are proactively controlled. Any risks introduced can cause potential roadblocks later in the development process, which can in turn lead to expensive and time-consuming solutions.
The term change control can be a bit of a misnomer, as it can imply that it is only used when changing from one process to another. Beginning a new process, or integrating a new vendor into your supply chain, is just as likely to introduce risk, and thus should be controlled in the same way.
Our change control process will ensure that you methodically consider all potential impacts in order to avoid introducing inadvertent risk when making changes or establishing new elements within your supply chain.
