5 Tips for Choosing a Reliable Testing Partner for Regulatory Success

Follow these tips when searching for the right third-party testing partner to avoid delays and ensure your product’s smooth journey to market.

Nick Christiano, Global Segment Leader - Biological Safety

May 6, 2024

4 Min Read
Image Credit: ilkercelik via iStock / Getty Images

At a Glance

  • It's important to choose a testing partner with a robust Quality Management System (QMS).
  • It is crucial to select a testing partner with internal regulatory affairs expertise.
  • Reliable data requires strict adherence to quality control measures and thorough analysis.

In the world of third-party laboratory testing, the stakes of choosing the wrong lab are high. Consequences can include unreliable results, re-testing, regulatory compliance issues, and legal liability. A successful partnership with a testing lab is built on trust, integrity, and a shared commitment to quality. However, other critical factors like cost, turnaround times, technical expertise, and proximity to your location will also play an integral role in the decision-making process. To avoid delays and ensure your product’s smooth journey to market, you will want to choose a lab that you can trust. Below are five tips to help you identify the right third-party testing partner.

Be sure that the lab has a strong quality system

As cost is often a determining factor, the cost of quality in a testing partner is essential to keep in mind. A quality management system (QMS) is essential to ensure the reliability of all aspects of testing. From safeguarding the accuracy and confidence of results to the implementation of quality control measures, a strong QMS contributes to greater trust in scientific findings. Choose a lab that is regularly audited by FDA and other regulatory bodies, in addition to one that performs regularly scheduled internal audits.

Nelson Labs Tip: Confirm your testing lab of choice has quality control processes and the appropriate documentation in place to ensure the accuracy and reliability of results. You may also want to inquire as to the frequency of external regulatory body audits.

Do a reality check on the turnaround times

Assess a laboratory’s ability to deliver testing results within your required timelines without any compromises on quality. While it can be tempting to choose a lab with the fastest turnaround times for an urgent project, the retesting or regulatory pushback that can result from unreliable testing data may ultimately do more harm than good and set you further back on your path to market approval. High-quality, reliable data you can trust comes with realistic timelines required to support critical sample preparation, strict quality control measures, and complex analysis.

Nelson Labs Tip: Inquire about your testing lab’s data integrity processes and discuss project complexities upfront. Ensure any needed adjustments to TAT have been reviewed by internal experts and are agreed upon prior to initiating testing so that they align with expectations.

Assess the internal regulatory resources

Internal regulatory affairs experts who understand the complexities of globally regulated manufacturers will lead to more successful testing outcomes. Selecting a third-party laboratory that offers in-house expertise in this area can help reduce the regulatory burden and even provide further support with unexpected feedback.

Nelson Labs Tip: Confirm that the lab has contributed to successful regulatory submissions for similar products. Inquire regarding the support they offer for questions from regulatory bodies that may arise during the submission process. Is the lab willing to stand by their data by discussing it over the phone with the FDA, for example, or do they take a hands-off approach when their data is in question?

Gauge the lab’s participation in standards development

Regular involvement at industry meetings, including standard development, keeps testing laboratories at the forefront of regulatory science and enables them to help manufacturers make the best testing decisions. Technical expertise and experience go a long way in the proper support and understanding of the ever-evolving world of standards.

Nelson Labs Tip: In addition to serving in an official capacity on standards committees, a testing lab offering a webinar, whitepaper, or other educational content on upcoming regulatory changes can also be a sign that the experts at that lab are up to date on cutting-edge information.

Verify that the lab has the appropriate, up-to-date accreditation (ISO 17025)

This one should go without saying, but the first sign of technical competence is accreditation to ISO 17025, which specifies the general requirements for carrying out tests and/or calibrations, including sampling. Compliance with the FDA’s ASCA program* can also be beneficial in addition to other industry-specific organizations. Accreditation demonstrates compliance with international standards and ensures the credibility of testing services.

Nelson Labs Tip: Confirm your testing lab of choice has the appropriate accreditations for the testing to be performed and ask if they have received ASCA or other accreditations to bolster their compliance with national and internal standards.

By evaluating the factors covered in the five steps above, you can identify a strong third-party testing partner to meet your specific testing needs and standards of quality, reliability, and competence.

About the Author(s)

Nick Christiano

Global Segment Leader - Biological Safety, Nelson Labs

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