Need Supply In Europe? Mind Your QPs "Ps And Qs"
By Louis Garguilo, Chief Editor, Outsourced Pharma
Biotechs outside of Europe continue to possess a stunted understanding of the role and responsibilities of the QP – Qualified Person.
It’s a simple sounding designation. What you need to know initially is straightforward:
If you are not using an appropriately EU-licensed importation site with an appropriately attached Qualified Person (QP), then no batch of yours will ever be released or approved for commercial or clinical trial use in the EU.
A QP is designated by the legal basis defined by a directive of the European Parliament, and held in accordance with national laws related to medical products.
You can hire QPs as your own employees, or contract for QPs on an as-needed basis at approved sites of manufacture and testing in the EU.
Who are these QPs? Who trains them? And what precisely do they accomplish?
Based in Ireland, she’s been a practicing, independent contract QP and quality consultant for some 22 years.
Buckle up with Buckley for an adventurous narrative over a few installations.
A few fundamentals and QP training seems like a good way to start us off.
Training Your Junior QP
I begin by asking for a case study for our readers, and Buckley readily obliges.
She documents work she has done in a QP consultant role for an established contract service company in the industry. A high volume of clinical batches needed in the EU has the client, among other things, looking to recruit what Buckley calls “junior QPs.”
In her role, she is providing a regulatory compliance review and gap analysis to improve the clients current “QP processes,” and she's educating “quite a number of people throughout the company” as to the regulatory requirements to execute importation, and thus required QP certification, in Europe.
Responsibilities, she says, “also include mentoring and training of the younger members of their staff.”
“I was asked to draw up about eight training presentations for new employees onboarding in the QP role at the client,” she explains. "They really need to understand their responsibilities when they're certifying a batch for clinical use in Europe.”
Supply chains today are complex; material can arrive from anywhere. Often (and unfortunately), the origins of materials that make up a batch lack a "proper, documented history of where, how, or even when they were manufactured."
Particularly with today’s drug sponsors operating under all-outsourcing models, Buckley says an important element of the job is performing “virtual QP certifications” for materials that arrive at the central importation site to the EU.
Managing this oversight necessitates close interactions between the certifying site’s QP and the sources of the material, be it a sponsor, CDMO, or other.
“When I’m facing sponsors and CDMOs,” Buckley says, “I try to educate these clients of the certifying site’s regulatory requirements when importing material from outside the EU, or for manufacturing material in Europe.”
“Facing sponsors" is an apt description.
At times, Buckley attests, they can be ... animated:
Why isn't the batch being released? Why are YOU [i.e., the QP] holding this up?
Buckley, with decades of experience, has learned how to calm them down enough to clearly annunciate her QP role and responsibility, and inform them of what further information or documentation she needs before she can give the green light to any batch for the mandatory “quality release.”
But getting back to the QP-trainees, I wonder how inexperienced new QPs might actually be?
“I think it’s a bit of a misnomer, the word ‘qualified,’” she says. Many new recruits are already experienced industry professionals, who have, perhaps, had adjacent roles.
The QP needs and most often has industry experience, and based on that experience and other factors, requires different forms/levels of training.
Fundamentally, they need to have their name officially attached to the site dealing with the importation or manufacture of specific materials or drug product.
Ultimately, says Buckley, “the competent health authority in each country has requirements around your background education, and decide whether specific courses need to be completed for full eligibility.”
These requirements can throw up some difficulties to becoming a certified QP, but given the importance of the role, they are not unreasonable.
It's not unusual, Buckley says, for a professional who has limited (or no) prior clinical batch-release or review experience to:
- go through a specified eight-to-ten-week training program before submitting their application to the competent authority;
- follow an outline of prior training against a new training plan, and considering education including specific qualifying post-graduate courses (usually an M.Sc), as well as the incumbent’s career background and relevant work experience.
The depth of prior experience may also dictate whether that training must be instructor-led, and whether practical training of batch review is required.
DYI?
At my request, Buckley sets down some of the experiences one can expect, and the reasons why one might take on, creating your own site of importation, and hiring your own QP, in Europe.
As an example, she uses a Marketing Authorization holder establishing an office in her home base of Ireland. This organization wants to set up its own importation site so it can certify its own batches.
Currently, it is experiencing delays at its contracted EU site of physical importation and with QP certification. The company feels there are too many “late requests” coming from the QP at the current site, the turnaround time is too slow, and there are delays in batch release.
Exacerbating the situation, the sponsor is experiencing drug and materials shortages.
And, Buckley points out, because shortages are a growing concern, “A sponsor having its own license to undertake QP certification is a perfect solution."
“In this specific example, their own QP then has direct relationships with any CDMO located outside the EU. That can be helpful."
That’s not to say, however, the road to successfully establishing your own authorized site and operations is smoothly paved.
“I’ve undertaken this work before,” she says. It includes, among other activities, acquiring the authorization approval from regulators, establishing suitable Pharmaceutical Quality Systems (PQS), meeting with the Health Products Regulatory Authority (HPRA), and implementing all proper procedures."
For missions like this, Buckley recounts the words of her first boss:
“Nollaig, you can beat eggs, but you cannot beat experience.”
Plenty more to unscramble here, and we’ll learn how Buckley gained her QP experience next.