QP Services and Oversight: Releasing IMP in a Post-Brexit World

The role of a Qualified Person (QP) in pharmaceutical manufacture was introduced to European law almost 50 years ago. As new technologies, globalization, and even politics have changed the clinical landscape over time, QP responsibilities and legislation have evolved. Two recent changes, and what they mean for clinical trial sponsors, are summarized here.

First, since the United Kingdom completed its Brexit transition on December 31, 2020, QPs named on a UK manufacturing/importation authorization (MIA) license may no longer certify clinical trial batches of investigational medicinal products (IMPs) intended for EU trial sites. Sponsors need to make sure they have an EU-based site of importation and QP if receiving IMPs from the UK for EU trials. Additionally, sponsors with only an EU-based MIA holder and QP will need to enlist a UK MIA holder if they intend to manufacture and/or distribute IMP within the UK, as an EU QP certification alone would no longer be accepted. As before, QPs need to be listed on the MIA license for the site of batch release.

Second, as of January 1, 2022, the MHRA implemented a new QP oversight requirement in Great Britain regarding the importation of IMPs from an approved country (currently all EU and EEA Member States). This involves an extensive assurance system to ensure IMPs coming into Great Britain have been QP-certified before they left an approved country. While routine tasks in the verification process may be delegated to appropriate staff on the quality team, a QP named on the UK MIA license must oversee the process itself. With QP oversight of imports in place, IMPs do not require recertification, saving sponsors from additional costs and delays.

QPs are a crucial part of the clinical trial supply chain. Their certifications allow IMP to be released to clinical trial sites or depots. They ensure that batches of IMP are manufactured per specification, according to GMP standards, and in compliance with government regulations. Their work generally involves supply chain verification, production record review, and additional assessments to determine that a batch is compliant and safe for human use.

QPs have degrees in a scientific discipline, such as biology, chemistry, or pharmacy, along with practical GMP-manufacturing or pharmaceutical experience. They deeply understand the unique requirements of running clinical trials in the UK and EU.

Xerimis has a team of highly skilled QPs who can support your clinical trials in the UK and EU. Contact us to learn more.

Xerimis Partners With Area Europe on State-of-the-Art Facility in the Netherlands

We’re thrilled to be working alongside Area Europe, a UK-based construction firm specializing in workplaces, on the design and fit-out of our environmentally sustainable facility in the Netherlands. The 45,000-square-foot site marks the new location for our next global depot, enabling us to increase operations in alignment with the growing needs of our clients.

Xerimis has been helping clients run worldwide clinical trials for the past two decades. In 2016, we elevated our global capabilities by opening our packaging and distribution facility in Theale, United Kingdom. Area successfully designed and delivered that facility. In 2021, with our next major expansion unfolding in the Netherlands, we turned to Area once again. This was an easy choice given their understanding of our business and their knowledge of European workplace culture.

Opening a new facility in the Netherlands will give our clients three tremendous benefits:

  • Easier entry for clinical supplies into mainland Europe since the completion of Brexit in December 2020.
  • Increased storage and service capabilities for investigational drugs, including those with specific temperature requirements.
  • Continued advantage of Xerimis’ commitment to quality, flexibility, reliability, and responsiveness — our core values.

A new benchmark for future workplace transformation

Located within minutes of Schiphol Airport near Amsterdam, the new facility sets a benchmark for future workplace transformation. Workspaces were strategically designed to provide flexibility for different types of work to be performed. While remaining consistent with our brand identity, site design was influenced by Dutch culture and workplace expectations.

An intensive six-month design phase took place with Area’s team guiding us through a comprehensive feasibility study and schematic development. With a focus on process workflow, we created a floor plan positioning certain functions in adjacency to others, optimizing space and flow while adhering to strict GMP (Good Manufacturing Practice) standards. We also organized and tested heavy equipment in the space to ensure functionality and compatibility with the design. In addition, we constructed a mezzanine to support workflow and future development.

“This monumental expansion comes on the heels of several years of growth for our company,” says Jim LoCascio, Vice President, Global Business and Strategic Development. It also positions Xerimis well for the expected uptick in clinical research throughout Europe, following the recent launch of the EU Clinical Trials Regulation. Furthermore, as pharma and biotech increasingly expand into new treatments requiring specialized temperature control, the facility is scaled to meet these needs.

Driven by innovation, integration, and sustainability

The site is the result of two new warehouse units integrated into one production and warehouse facility. Designed to create harmony between functions, directional guidelines show the path to changing room and shower amenities, canteen, front offices, and meeting suites. Natural materials are used throughout, with matte black metal detailing seen in joinery, glazing, and feature staircase hardware. Xerimis brand color accents the space through soft furnishings and artwork. Separate air handling systems were built into the scheme for the clinical packaging, labeling, and storage areas.

On the production floor, modular ultra-cold units provide conditions required for temperature-sensitive drug storage as low as -80° C. The walk-in freezer offers abundant shelving for product storage with ample space for manoeuvring pallet jacks, and the walk-in refrigerator — large enough to drive in and operate forklifts — can accommodate over 350 pallets. The site is equipped with advanced temperature monitoring and backup systems to ensure consistent climate for inventory protection.

With significant power required to run the site, we’ve been focused on sustainable and efficient energy since early in the design stages. We leased the building’s roof and installed a solar array that will generate over 200 kVA of electricity. This solution is supported by a backup battery system, with redundant power provided by backup generators and grid electricity.

Area has been onsite since October 2021 and will carry this landmark project to completion by May 2022. “Distance has been no obstacle,” says Lee Day, Director of European Projects at Area. “Despite COVID-19 travel restrictions, we have worked collaboratively with Xerimis NL, UK, and US-based project teams to co-create this state-of-the-art facility. We are very proud to be supporting Xerimis’ growth strategy in line with the intricacies of local codes, statutory requirements and regulations.”

We’re grateful for our partnership with Area. They’ve done a remarkable job steering our construction and designing a facility bespoke to our unique business. We look forward to opening our Netherlands depot later this year.


EU Clinical Trials Regulation Is Here

The EU Clinical Trials Regulation (CTR) has been in the works since 2014, but now that it’s actually here, what are the basics you need to know?

The CTR, which went into effect on January 31, 2022, harmonizes the assessment, approval, and supervision of clinical trials throughout the EU via a central database, the Clinical Trials Information System (CTIS). The new Regulation was created to promote clinical research in the EU by streamlining the clinical trial application (CTA) process, while improving transparency on trials by making information accessible to the public.

Under the previous process, known as the Clinical Trials Directive (CTD), running a multi-country trial in the EU meant the sponsor had to send a separate CTA to the competent authorities and ethics committees of each country targeted. Then each country had to authorize the trial based on its own adaptation of the CTD into national regulations, which varied between countries. Inefficient and costly, the process ultimately hindered clinical research in the EU.

Under the new Regulation, sponsors may submit a single CTA through the CTIS, which allows for parallel review by EU/EEA Member States. The CTA is a two-part dossier: Part I involves general information about the trial, and a lead Member State (proposed by the sponsor) coordinates and reports a collective response from contributing Member States; Part II involves country-specific information, and sponsors complete a Part II for each Member State concerned. Within a set timeline, each Member State concerned must notify the sponsor of its decision via the CTIS. 

Transition period for clinical trial sponsors

From January 31, 2022 through January 30, 2023, sponsors have two choices for CTA submission: 

  • Apply using the CTD system, EudraCT (with individual submission for each targeted Member State). Approved trials may follow regulations per CTD until January 30, 2025.
  • Apply using the CTIS (simultaneous submission for up to 27 EU Member States plus Iceland, Liechtenstein and Norway). Approved trials will be immediately governed by the CTR.

Starting January 31, 2023, any sponsor seeking to run an EU/EEA trial must submit a CTA through the CTIS. 

By January 31, 2025, any ongoing trial that had been approved under the CTD must be transitioned to CTIS for governance through the new Regulation.

New considerations for sponsors

The timeline for initial CTA approval ranges from 60 to 106 days under the CTR. However, amendments may not be made until after initial approval is granted. Then, adding a country or clinical site will trigger a new review period. Therefore, sponsors are urged to select countries and clinical sites carefully when planning their submission. 

In addition, since EU countries could have simultaneous approval of Part II, all EU sites could potentially have a shipment request go live overnight, depending on the sponsor’s clinical site initiation policies and IRT management. Sponsors will need to be ready with supply and distribution in place. 

Sponsors may also consider alternate strategies for completing Parts I and II of a CTA. There may be reasons, for example, to submit Part I and Part II sequentially (within a two-year deadline), or to include only some countries in Part II initially, with plans to phase in additional countries. 

Xerimis expertise to help guide sponsors

With the CTR comes much to know about the application process, timelines, record handling, Annex VI (the stricter packaging and labeling laws coinciding with CTR), slightly different Good Manufacturing Practices (GMPs) and more. Xerimis created a webinar explaining key points of the new Regulation and Annex VI. 

For more information on how Xerimis can help your EU clinical trial stay on track, contact us today.

COVID-19 Update: Vital Operations Continue at Xerimis

On Saturday, March 21st, the Governor of New Jersey issued an Executive Order No. 107 requiring all Non-Essential Retail Businesses to close. Xerimis is not forced to close our business since Xerimis is part of the pharmaceutical supply chain responsible for providing medicines to patients, and as such is considered in the category defined as Healthcare/Life Sustaining businesses.

The ongoing efforts to contain the spread of the COVID-19 virus throughout the world make this a very dynamic time for individuals and businesses alike. Xerimis continues our commitment to the safety of our clients, patients, and team members. We have transitioned many Xerimis employees to remote working to the greatest extent possible. We continue with our on-site activities including receiving, packaging, distribution and returns accountability and have implemented aggressive cleaning procedures for all areas of the building.  Our staff is already cross trained which will allow us to perform the most critical activities at Xerimis.

We are working collaboratively with all clients to ensure supplies are packaged and dispatched as planned.  We recognize the impact of COVID-19 and the new challenges that are being presented to sponsors.  We are actively working with our partner couriers to set up direct to patient delivery when this option becomes necessary due to circumstances related to COVID-19. We will work with clients to ensure we prioritize the most critical needs for patients.

We have begun seeing countries impacted by the COVID-19 virus and shipping lanes being impacted. We continue to keep our clients updated regularly and look for alternatives as needed. The likelihood of disruption to other geographical areas cannot be ruled out with each passing day. We are committed to our partnership with you and to being here to support you and patients in this most serious time for our world.

Carol Sue Bernardo