Qualifying Expertise for Quality Support

Magnifying glass and check mark icon. Business concept,idea,right choice, quality control, approval and contract assignment | Image Credit: ©olyphotostories - stock.adobe.com

The bio/pharmaceutical industry is, understandably, strictly regulated and, as such, companies seeking commercialization of a therapeutic product must ensure they meet the relevant requirements at all stages of development through to dossier submission and beyond. Unfortunately, the breadth of knowledge and level of expertise required to ensure full regulatory compliance, the requirements for which can differ depending upon geographic location, is not always found within a company’s internal team.

However, when seeking out support for quality-related matters and regulatory affairs, sponsor companies need to understand how to qualify external employees or consultants correctly to avoid potential pitfalls and issues with the regulatory authorities later down the line.

Applying modern technologies in development

Artificial intelligence (AI) is being increasingly used across many aspects of everyday life. Within the bio/pharmaceutical industry, AI is also being employed for various tasks, including formulation of novel drug products. However, with novel technologies comes uncertainty and usually a lack of expertise.

“Of course, using modern methodologies, technologies, is not only making sense from a commercial perspective, but the regulators are also really encouraging [their use],” remarked Siegfried Schmitt, vice president, Technical at Parexel, during episode two of Pharmaceutical Technology®’s Ask the Expert video series (1). “Now, when you apply something that new, then it’s very likely that you may need external support by experts, external experts, and when you use a third party to help you, especially with GMP [good manufacturing practice], GxP [good practice]-related activities like development, then you need to apply some vendor assessment process.”

Yet, with such a new technology, Susan J. Schniepp, distinguished fellow and quality assurance expert at Regulatory Compliance Associates, a Nelson Labs company, questioned how it is even possible to qualify the external experts that will be required. “I think, when putting in an AI system or looking at it, the one thing I would highly recommend companies do is quality management risk assessment,” she noted. “[Companies] cannot put in a system without doing that very comprehensive risk assessment.”

Requirements for submitting regulatory applications

When specifically looking at the requirements for a new drug (NDA) or biologics license applications (BLA), Schniepp explained, during episode three of the Ask the Expert video series (2), there is basic information that is required, which can be easily researched on FDA’s website.

FDA provides guidance on the information that they require to ensure successful submission of an NDA (3) or BLA (4), including notes on critical information that, if it isn’t included, will mean rejection of the application as an incomplete file, Schniepp added. “But the best way to make sure that you’re giving [FDA] what they need is to really talk with them,” she said.

Communication with the agency is particularly imperative when dealing with novel biologic therapeutics, Schniepp advised. “When we talk about ATMPs [advanced therapeutic medicinal products] that are probably going to go in a BLA, [there will be] a lot of complications, and [companies] need to be working with the agency up front to make sure [they] are handling those filing issues,” she noted.

“It’s not just with FDA,” continued Schmitt in the same Ask the Expert video series episode (2). “All the agencies I know of have provided the opportunity to applicants for pre-approval meetings, pre-submission meetings, and you should take note of this and make good use of it.”

Within the biologics space too, Schmitt explained that many companies are smaller in size. “Of course, these [companies] are the ones who need the most support, and when you look at the agencies, they have special support programs for such companies,” he said. “Now, of course, [the company] can ask the agency [and they] hopefully have some in-house expertise, but again, it is sensible to understand, where are the gaps? Where would [the company] perhaps need external support?”

Understanding the need for the right people

For smaller companies, the expertise is not always available in-house, leading to some companies outsourcing quality functions, Schniepp specified. “But the relationship of how [a company] qualifies contract employees or consultants is very critical,” she asserted.

As quality consultants themselves, Schniepp and Schmitt emphasized that they need their clients, the sponsor company seeking expert assistance, to understand all the relevant background information and not simply choose a quality consultant based solely on the cheapest price option. “[Companies] need to look into the consulting firms they’re going to use and make sure they have the right expertise to support the [regulatory] filing,” Schniepp explained.

“[Companies] have to understand when outsourcing critical functions that [it is imperative] to have the right people,” Schniepp continued. Ultimately, when the filing has been completed, the consultant’s work is done and they are no longer needed, which means the sponsor company must understand the work that has been done to complete the filing as they are then responsible in the eyes of the regulator, she stressed.

If a company hires a quality consultant who doesn’t have the expertise needed for the task, but they were the cheapest for example, then there will more than likely be regulatory problems later down the road, Schniepp warned.

“[Companies] need to have a quality system that makes sure that whatever external support [they’re] calling for [they] select those who are most suitable for [their] needs and can provide quality expertise,” confirmed Schmitt.

References

1. Thomas, F.; Haigney, S. Quality Considerations for Using AI in Bio/Pharma. PharmTech.com, July. 24, 2024.
2. Thomas, F.; Haigney, S. Submitting Regulatory Applications Connects to Quality. PharmTech.com, Aug. 22, 2024.
3. FDA. New Drug Application (NDA). www.fda.gov/drugs/types-applications/new-drug-application-nda (accessed March 20, 2025).
4. FDA. Biologics License Applications (BLA) Process (CBER). www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber (accessed March 20, 2025).

About the author

Felicity Thomas is former associate editorial director of Pharmaceutical Technology®.

Article details

Pharmaceutical Technology®
Vol. 49, No. 3
April 2025
Pages: 32-33

Citation

When referring to this article, please cite it as Thomas, F. Qualifying Expertise for Quality Support. Pharmaceutical Technology 2025 49 (3).