Understanding Your Outsourcing Responsibilities
Are you selecting your CMOs wisely? As a sponsor choosing a CMO, it is easy to assume that any new CMO must have an on-site audit conducted as part of the selection process. But is this really the case? JWQC can offer you an alternative system of Vendor Qualification, prescribed to each individual CMO, that can help you to decide the most effective time to undertake an audit.
In order to understand whether a vendor is suitable for your supply chain there are steps that can be taken to help you eliminate future difficulties and costs that come with choosing unsuitable vendors for your product. Our Vendor Qualification is an efficient and effective process, methodically working through potential pitfalls to minimise the risk of these problems occurring.
Our Oversight Offerings
Quality Agreements with Outsourced Partners
When outsourcing GMP activities a Quality Agreement is needed between all relevant partners in your GMP supply chain to delegate GMP responsibilities to the appropriate party and to ensure effective communication. Without the Quality Agreement there is a risk that responsibilities are misunderstood, or GMP requirements are not met, leading to serious implications for the safety and quality of your IMP.
The agreement also gives you an insight into the processes and systems of your CMOs to create an effective future working relationship. JWQC has developed a quality agreement checklist, using their experience taken from working with a wide range of outsourced CMOs, and QPs. Our checklist can be used to review and implement all types of Quality Agreement. Please contact us here if you would like more information.
Vendor Regulatory Review
Audits are expensive and time consuming for any sponsor, but are not necessarily your first port of call when selecting your vendors. A Vendor Regulatory Review (VRR) is a discrete service that can help to confirm GMP compliance status, and the licence suitability and applicability of your chosen vendor.
Sponsors and/or Marketing Authorisation Holders have a responsibility to ensure that all of their outsourced vendors hold, and continue to hold, the appropriate registrations, licences, and certifications which authorise them to perform the required GMP/GDP activities relating to their medicinal product manufacture.
There is a significant risk to product quality, patient safety, as well as your budget, should organisations be used where their compliance with the principles and guidelines of GMP/GDP cannot be assured.
JWQC can help you to confirm the regulatory status of all your vendors prior to the initiation of GMP activities, by completion of a bespoke Vendor Regulatory Review process for each individual CMO. Completion of this process will ensure that all your vendors have the appropriate certification and licenses, country and competent authority applicable, to manufacture your Bulk drug substance, Active pharmaceutical ingredient (API), Intermediate and Final Bulk Drug Product.
GMP Assessment
As sponsors, audits are used as a tool to prove that you are meeting your vendor oversight responsibilities according to EU GMP (or equivalent). But why run before you can walk? A GMP Assessment can be an effective method of carrying out your GMP related responsibilities without the need for an expensive upfront audit.
Using a GMP Assessment we can learn how your CMO is going to control the manufacturing process so that it meets your needs, as the sponsor, and the regulator. We can check that there are systems in place that should cover areas of risk, so that potential roadblocks can be identified before they become an issue.
Of course, there is no one size fits all solution to every situation, and our GMP assessments can be adapted to fit your requirements, so for more help on how you should be proceeding with your oversight, contact us here.
Audit
NB. All CMOs should be audited at some point. However, this does not need to be your first port of call, as illustrated in the other sections on this page. We advise reading these sections so that you can understand when it is the most efficient and effective time for you to undertake your audits.
Using an audit we can assess whether the information provided by your CMO is being enacted in a successful manner, and whether it manages to control the risks involved in the manufacturing process. Sometimes it can be more effective to audit at first – if for example a CMO proves difficult to obtain the required information from – but each case is different. If you want assistance in deciding which route to take, contact us here.
Audits are the final, and essential, option for an in-depth assessment of your CMO’s GMP systems. This is the opportunity for your CMO to prove that they are capable of manufacturing your product in a safe manner, on an ongoing basis.
JWQC has a wide range of auditing experience at all stages of drug development, covering a range of dosage forms. We have significant experience performing GMP audits of non-sterile and sterile product manufacturers, including for ATMPs and cell-based products. Our auditors include QPs, Microbiologists, and PQS Specialists, and can provide tailored audits relevant to your specific supply chain needs.
