In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of experience managing Quality aspects of product and process development, to successfully release CGT product to clinical trials or to market in the EU, US, UK, and RoW.
QP batch release is required to be in accordance with EU requirements (Commission Delegated Regulation (EU) 2017/1569 and Regulation 536/2014) on Investigational Medicinal Products (IMP) covering both sterile and non-steriledosage forms. QP and Quality Services offered by Hitech Health include contractual QP services, for both general Quality consultancy and batch release, for short and long-term contracts.
The QP and Quality Services include:
Supporting and maintaining all aspects of Quality Management System (QMS) compliance.
Designing and implementing a robust supplier qualification program and effective management of this process.
Importation and QP Certification.
With Hitech Health holding the Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU, CGT products can be imported and released to EU clinical trials in a matter of months.
Hitech Health has QPs specialising in the CGT and ATMP field and can offer quality support for the successful release of your CGT product. By partnering with us and working with our experienced cross-functional team under our already approved MIAs, you reduce personnel and regulatory cost, thereby making considerable financial and time savings in getting your product to the clinic or market.
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Hitech Health’s Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate’s Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for developers, investors and solution providers whose goal is to bring cell and gene therapies to patients. We are really looking forward to the event and will be available for partnering meetings to discuss how we can help your advanced therapy processes and reach your goals.
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head of Commercial for Hitech Health, effective 1st December 2022. In this role, Clare will lead the Business Development and Marketing for Hitech Health, providing the full Contract Development and Manufacturing Operations (CDMO) services for Cell and Gene Therapy Drug Development.”
Brian adds: “Clare has over 20 years industry experience and has held various roles in QA, QC, Regulatory Affairs as well as Operational Leadership. The majority of her experience has been in clinical drug development with an additional 2 years spent working in a GMP setting. Most recently she led the global Business Development teams for two divisions of a Global CRO.”
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in 20221. The US Food and Drug Administration (FDA) expects that they will receive more than 200 investigational new drugs (INDs) per year, building on the more than 800 active cell therapy or directly administered gene therapy INDs currently submitted to the FDA2. The diverse and complex nature of CGTs can often make regulatory affairs matters more intricate than traditional pharmaceutical products.
To meet the demand for advanced medicines, the FDA announced in the Federal Register that the Office of Tissue and Advanced Therapies (OTAT) in the Center for Biologics Research and Evaluation (CBER) has been changed to the Office of Therapeutic Products (OTP) and upgraded to a “Super Office” that should significantly improve the efficiency of the workflow for reviewing regulatory submissions. This will include therapeutic tissue-engineered products, human cell and tissue products and combination products, as well as gene therapies that result in persistent cellular modifications.
This initiative has also received significant financial support from the US Congress. More products will be able to be reviewed and supported by the knowledge of more scientific experts, which should help companies to launch their products in a timely manner. Advanced medicines such as CGTs are often intended to meet unmet medical needs and the steps taken by the FDA are a positive move to ensure patients receive life-changing treatments.
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The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in accordance with EU Good Manufacturing Practice (GMP) guidelines if the products are destined for the EU market. It is imperative to ensure that products are consistently manufactured and controlled according to quality standards.
This article outlines key considerations when importing medicinal products from outside the EU.
Manufacturer/Importer Authorisation (MIA)
To import products into the EU, wholesale distributors receiving medicinal products from third countries must hold a Manufacturer/Importer Authorisation (MIA) for the site where QP certification and physical importation occur. MIA is also required if the location where batch certification is performed is different from the location where the imported product is physically received.
Importers are required to adhere to GMP standards as MIA holders, which include setting up a pharmaceutical quality system, having sufficient personnel and workspace for the relevant activities, planning appropriately for the handling of complaints and recalls, and putting protocols in place to manage their supply chains.
Following Chapter 7 of the EU GMP guidelines, a written agreement should be signed between the premises engaged in manufacturing and importation activities and the Marketing Authorisation Holder (MAH), and should set out the respective responsibilities of the MAH, the importer, the QP certification site and the third country manufacturer.
Qualified Person (QP) Certification and Quality Control Testing of Imported Medicinal Products
Imported medicinal products must be physically imported and cleared through the customs territory of an EU country and then stored under quarantine upon receipt until released for QP certification. It is a legal requirement that the QP certify the batch to ensure that all medicinal products imported from third countries are manufactured under the EU GMP standards and that products will be tested when imported into the EU unless there is a Mutual Recognition Agreement (MRA) or Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA).
Full batch documentation must be provided to the MIA holder responsible for the QP certification of the batch to ensure continued product quality. (see Annex 21 of the EU GMP guidelines for details)
Relevant ordering and delivery documentation should be included in batch documentation, such as the details of transportation (e.g., temperature monitoring records).
If batches have been subdivided and individual quantities imported separately, documentation confirming quantity reconciliation should be provided at the QP certification site.
Details of the on-going stability programme, such as protocols, results and reports, should also be available for inspection at the QP certification site, as required in Chapter 6 of the EU GMP guidelines.
All documentation must be kept in compliance with the standards of Chapter 4 of the EU GMP Guidelines. Additionally, the certifying QP oversees making sure that reference and retention samples were obtained in compliance with relevant GMP for Investigational Medicinal Products (IMPs) guidelines as well as the criteria in Annex 19 of the EU GMP guidelines. Furthermore, all batches of medicinal products where a MRA is not present must undergo quality control testing in an EU based laboratory (e.g., a contract laboratory) to help ensure the quality and safety of the products entering the destination country.
The QP will certify the batch upon approval of the batch testing results listed below: (see Annex 16 of the EU GMP guidelines for details)
Quantitative and qualitative analysis of active ingredients and related medicine components. All the other tests or checks necessary to ensure the quality of medicinal products is in accordance with the requirements of the MA.
Importer of Record (IoR)
During importation, an Importer of Record (IOR) in the destination country is required, as they are responsible for ensuring that the medical devices/goods are imported in accordance with the laws and regulations of the importing country. The following documents are example requirements:
Product Classification – details of the category and value of the imports.
Import and Export licenses – permission to import products.
Fees/Taxes/Duties – documents when paying related fees, taxes or duties.
In addition, the IOR also needs a valid Value Added Tax (VAT) number and a valid EU Economic Operator Registration and Identification (EORI) number, which can be applied to the local tax authorities (usually the EU country where the imported products will arrive) as an identification number for all customs procedures when exchanging information with the EU customs authorities.
Contact us today for further information on importation of medicinal products into the EU. HiTech Health holds Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU. By partnering with us and working with our experienced cross-functional team under our already approved MIAs, you reduce personnel and regulatory cost, thereby making considerable financial and time savings in getting your product to the clinic or market. HiTech Health have a team of Qualified Persons (QPs) and Responsible Persons (RPs) available to support your product portfolio.
HiTech Health is delighted to be selected as the ‘Spotlight’ company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight.
HiTech Health is a full-service Contract Development and Manufacturing Organisation (CDMO) in the cell and gene therapy space. We have added GMP Clean Rooms to our state-of-the-art laboratories in Galway, allowing for the manufacture of clinical materials. This adds significantly to existing capabilities which includes process, analytical development and supporting services.
Please email email@example.com to request further information on the range of services HiTech Health can provide.