This is the second of our “Ask the Expert” blogs, a series featuring the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. Members of the Quality and Regulatory Affairs team at Pearl Pathways were interviewed for this post.
If you have any regulatory, quality, or clinical development questions for Pearl Pathways’ advisors, forward them to us and we will provide answers in future posts.
Q: Why is qualifying vendors so important?
A: FDA expects sponsors/manufacturers to have a quality system to ensure that the device or drug is made the same way every time and offers reliable quality. An essential part of that is knowing that your vendors won’t let you down. You could, for example, spend six figures on animal studies only to find out that the quality of the work is unacceptable, and the studies must be repeated with a different lab.
“We recommend that clients start [a quality system] on day one. The system doesn’t need to be as complex as what exists at large biotech companies, but there must be a few SOPs in place.”
Q: How soon does a new company need a quality system?
A: We recommend that clients start on day one. The system doesn’t need to be as complex as what exists at large biotech companies, but there must be a few standard operating procedures (SOPs) in place. One of the first SOPs must detail the procedures for qualifying vendors so that you can be sure that what a vendor provides will meet your own standards as well as the FDA’s.
Q: What does qualifying a vendor entail?
A: You look at the systems they have implemented. Are they doing things that ensure compliance to applicable standards and regulations? Are their internal systems set up to ensure data integrity and product quality? Qualifying a vendor ensures that you have a reliable partner with the systems in place to meet your requirements as the sponsor/manufacturer.
Q: What standards should a company be checking against? Who has established “the standards”?
A: We generally work against the International Organization for Standards (ISO). They provide a standard for quality systems. Other standards include guidance published by the International Conference on Harmonization (ICH), in addition to national, local, and industry standards.
Q: Problems do occur. How do you assess the severity of them?
A: When there has been a problem, we want to know what the processes are for identifying a root cause and implementing corrective actions to resolve it. Also, we consider how long it takes for the problem to be resolved and review the preventive actions to ensure the problem does not happen again. We had one client who had excellent processes, but the average time to achieve a resolution was never. They never achieved resolution. That is a red flag for an auditor of an inadequate quality system.
Q: Could you share an example of a specific quality problem you uncovered while qualifying a vendor?
A: We had a client who manufactured nutraceuticals, some of which were chocolate coated. We were qualifying a warehouse for this client. One of the first questions we asked the warehouse manager was how they were controlling the temperature in the warehouse. This was an important question because summer temperatures in this area could exceed 90 degrees, thus melting the chocolate coating. The vendor stated that they did not have temperature control in the warehouse. The facility was great and the warehouse vendor was doing lots of things correctly, but we couldn’t recommend this warehouse to our client because of the temperature concern. Sometimes the issue is as simple as that.
Q: Is qualifying vendors a once-and-done procedure or an ongoing process?
A: Generally, we’ll do an initial audit to make sure they have the systems in place to align with FDA requirements, etc. Depending on the criticality of the good or services provided, an annual audit may be required, or completion of a periodic questionnaire may be sufficient to maintain supplier files. Sponsors/manufacturers will perform inspections of delivered goods as they come in to make sure they are appropriate and meet the requirements specified. Over time, as a vendor establishes credibility for consistently delivering high-quality material, sponsors/manufacturers may reduce the frequency of testing, in accordance with regulatory requirements.
Do you have a question for the next Ask the Expert blog? Forward it to us at contact@pearlpathways.com. We look forward to hearing from you.