Quality control to begin the regulatory journey
The regulatory journey began with seemingly routine technical questions, posed by Ferring’s Quality Control (QC) team. These questions soon revealed themselves as key components of the FDA submission process.
“We did a lot of back and forth because they were preparing,” explained Ferring’s supply chain team. Although some queries appeared unrelated to regulatory filing, each detail contributed to building the robust data package needed for submission.
Adelphi’s role in the journey
Adelphi's role extended far beyond supplying packaging. They responded quickly to technical questions, validated document requests, and provided regulatory clarifications. That enabled Ferring to maintain momentum throughout the submission process.
“Sometimes, you just need to know you’ll get an answer back without following up,” the Ferring representative noted, highlighting the trust and efficiency that marked the relationship.
A direct commendation from the FDA
The FDA's direct commendation of Ferring’s vendor qualification process stood as a testament to this collaboration. "The FDA said our vendor qualification portion was very well executed," shared the supply chain lead.
This praise reflected not only Ferring’s internal dedication but also Adelphi’s responsiveness in providing essential quality and compliance documentation.
Entering new markets
The regulatory complexity increased as Ferring prepared to enter new markets such as Canada. Different regions impose varying documentation standards, such as nitrosamine content declarations. Adelphi remained a valuable resource in navigating these requirements.
“Sometimes you get a yes/no question, sometimes it’s a nuanced technical question, but having that relationship is key. And with Adelphi neither type of question is a problem,” explained the team.
Overcoming challenges
Annex 1 was identified as a critical area of focus. It’s the European regulation governing sterile pharmaceutical manufacturing. “Changes in Annex 1 could impact how our equipment is qualified,” Ferring noted.
These evolving standards demand continual diligence, training, and adaptation – a challenge made easier through transparent supplier partnerships.
Operational hurdles also tested the team's resilience, including the advanced VanRx automated filling machine. Central to the project, it introduced new levels of precision, efficiency, and product protection.
"When the machine runs well, it delivers exceptional consistency and quality, helping us meet the highest standards for sterile manufacturing," shared one team member.
Combined with carefully selected packaging components, the system's advanced capabilities play a key role in ensuring the safe and efficient production of this innovative treatment.
What’s next?
Looking ahead, Ferring aims to further streamline regulatory submissions for global markets – using lessons from this launch as a blueprint. By continuously strengthening relationships with trusted suppliers, they are better positioned to navigate future audits, market expansions, and regulatory changes.
Above all else, this partnership underscores the value of supplier collaboration in achieving regulatory excellence. With the right partners, even the most complex submissions can succeed – benefiting patients and healthcare systems alike.
