The modern medical life science industry is a multiple-wheeled machine. It takes a lot of groups working in tandem to get a medical product on the market. While the majority of the production and assembling might happen in the manufacturing facilities, a lot of the work happens behind the scenes; starting with the suppliers.
There are hundreds of niche companies that act as suppliers to larger companies. They take on small parts of the process and focus on perfecting it. For example, some suppliers create one or two specific machinery, some collect and refine high-quality raw materials, some create packaging, etc.
So much of the process is now outsourced, thus, maintaining quality and following standards can be difficult. There are simply too many operations, all going on at the same time. If every component of the supply chain is not properly vetted it can affect the end product, increasing risk and eventually the final cost. Ensuring supplier qualification can save your organization from these consequences.
What is supplier qualification?
To ensure suppliers are providing the very best quality products, you need to take an in-depth look at the supplier's end of things. Supplier qualification does exactly that. It is an extensive process that helps both suppliers and businesses run smoothly.
The supplier qualification process is a lot more “in-depth” than performing audits. It’s essentially a risk assessment and quality management process. It is a standard practice to ensure that suppliers maintain quality and meet regulatory requirements.
Supplier qualification is also a great tool for choosing the best vendors, suppliers, and contractors. The process involves vetting the suppliers before making an agreement with them. As the process gives a comprehensive overview of each supplier, it helps businesses to make an informed decision easier.
Also, your options will be narrowed down because only those that meet the requirements of your company will be eligible. The process benefits manufacturers both long and short-term.
Recommended learning: Your top questions answered about complying with cGMP in the pharmaceutical industry
Is supplier qualification a regulatory requirement?
Yes, ensuring supplier qualification is a regulatory requirement. Most regulatory authorities set their standards based on safety requirements and risk management.
FDA requires manufacturers to audit, assess, and maintain supplier qualification. FDA 21 CFR 211 sets the requirement for vendor qualification. They provide detailed guidelines for companies to follow, including summary QMS, testing protocols, history of recalls, etc. FDA expects manufacturers to reassess and check the supplier quality systems routinely and update/terminate contracts as necessary. They also expect manufacturers to routinely test the supplied materials/services at routine intervals.
Other international regulatory organizations also put emphasis on ensuring contractor, vendor, or supplier quality. Similar to the US, the European Union also puts the task of verifying supplier quality onto the manufacturers. The EU requires the submission of confirmation of supplier qualification of active substance suppliers through audits. GMP is considered the standard according to the EU.
Supplier qualification process
Supplier qualification assessment can be a lengthy process. However, following the correct guidelines, having a checklist, and focusing on key factors can speed up the process. This following format shown in the infographic below works well for all life sciences sectors, but you can tweak the details to match your requirements.
Define company requirements
The first step is to determine what you, the manufacturer, requires from the supplier. The supplier qualification depends largely on this first step. the goal is to create documents outlining technical aspects of your products, the market standard, safety measures associated with them, the ideal delivery time your company can work with, associated quality certifications (ex, ISO cert.), and budget. This will take collaboration between design, production, and management teams. Once you have your outline ready, you can send the details out to potential suppliers.
Identify and assess potential suppliers
After the initial requirements are met, it shouldn’t take too much to get an initial list of potential suppliers. You can also do market research and connect to organizations that seem to fit your criteria. At this step, it’s important to engage and evaluate the candidates. The qualification assessment starts at this stage.
Ask the suppliers to provide documents showing their QMS and other associated documents and have meetings discussing regulatory compliance and quality. You should also be able to verify whether they match your technical requirements and budget as well. It’s a good time for risk screening. Making a checklist prior to this step helps shortlisting candidates faster and efficiently.
Create a shortlist
The next step is to shortlist the suppliers. There are no specific numbers, but choosing between two to three choices is easier. Hence, keep the list as short as you can.
Conduct comprehensive evaluation
The next step is to do an extensive assessment of the chosen supplier/contractors. For this step, the best practice is to follow an international guideline. Your team needs to go through their documents thoroughly and check all data sent. You can also request samples of products/services for further evaluation. In addition to off-site assessments, it’s best to do an on-site audit as well.
Since this assessment is the most elaborate one, it needs to be foolproof. It should also be well documented. All assessments done at this stage can also be part of the proof of verification that the EU and FDA require.
Select the preferred supplier
The following step is to select the supplier/contractor/vendor. By this step, you should have enough information to select the supplier that suits you best. Draw up an initial agreement for a test run.
Finalize the agreement
Before finalizing with your selected supplier, go over the potential risks and risk management plans. The selected supplier should have plans for the most probable scenarios like natural disasters, supply chain failures, technical failures, etc.
During the initial stage, monitor the supplier’s performance. Some important factors to note here are the delivery time, adherence to regulatory compliance, delivery quality, communication, etc. Having a list of key performance metrics and sharing it with the suppliers helps set clear expectations. For both your and their teams, you can arrange workshops and management training for smooth collaboration. Establishing proper safety measures and backup plans is also key at this point.
Perform ongoing audits and reviews
If the trial period goes well, it will pave the way for long-term collaboration. In that case, having a written legal agreement benefits both parties. However, the supplier qualification process also involves periodic review and monitoring.
Plan for continuous risk management and regular audits. Ideally, you should also plan for surprise on-site audits and regular performance reviews. Manage expectations through regular feedback for quality maintenance and improvement.
Scilife tips
Each company is different, each QA person's job is different and so is every supplier qualification process. Creating a system for regular checks that works for you is a good strategy, however, you still need to follow a standardized method. Going over international guidelines might be helpful. Here are some reading materials you can take a look at:
Conclusion
The supplier qualification process is a critical component in ensuring the integrity and quality of products within the life sciences industry. By meticulously assessing and selecting suppliers based on rigorous criteria, you can mitigate risks, enhance compliance with regulatory standards, and ultimately deliver superior products to the market. This proactive approach not only safeguards the end product but also fosters strong partnerships with suppliers who are committed to excellence. As the landscape of life sciences manufacturing continues to evolve, embracing a robust supplier qualification strategy will be essential for you to thrive in a competitive environment.
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