Meeting the most stringent requirements for your ultimate certainty
Achieving excellence in regulatory compliance
At Cryoport Systems, we understand the critical importance of compliance with pharmaceutical industry regulations. Acting as an extension of your organization’s quality department, our quality management system is designed to meet international pharmaceutical regulations. You can rest assured that all aspects of our operations from staff training to standard operating procedures (SOPs), CAPA procedures, and change controls are managed by our experienced quality team.
An extended network of quality
Expert navigation through complex regulatory environments
Our EU locations provide Qualified Person (QP) oversight of import and release (as required by EU Clinical Trials Directive 2001/20/EC) with experts who can navigate the complex regulatory environment of European clinical trial applications. These services work to expedite the smooth transportation of irreplicable clinical and commercial samples across borders, offering expert guidance and peace of mind to our clients that their materials are handled compliantly throughout their journey.
Cryoport Systems’ QPs have earned the highest credentials in accordance with the European Union standards and requirements. Each QP is academically qualified in pharmacy, chemistry, or biology. Their continuous professional development also ensures their understanding of and adherence to legislation impacting operations and our clients’ products. The breadth and depth of experience our QPs have means that they can deal quickly and expertly with the special issues and technical challenges with Advanced Therapeutic Medicinal Products (ATMPs).
We extend our quality oversight into our vendor network, which is highly qualified and frequently audited. This ensures compliance with the strict standards required for the management of high value, irreplaceable materials. Our continual improvement programs ensure our processes are constantly reviewed and optimized to bring excellence in both service and operational performance. Our team of quality professionals are always on hand to provide advice and guidance or more formal consultation. They’re here to help you with the design of your clinical supplies’ management both domestically and internationally.
Qualified Person (QP) Services
GMP regulations are established and maintained in the US by the Food and Drug Administration (FDA). The European Medicines Agency (EMA) oversees the European Good Manufacturing Practices (GMPs). The quality processes for complying with the guidelines of each regulatory agency are relatively similar but differ in that the title of the person responsible for most of the quality processes and tasks and batch certification is the Qualified Person (QP) within the European Union (EU).
When you carry out clinical trials within the European Union (EU) using investigational medicinal products (IMPs) that have been manufactured and/or tested outside the EU, a QP is required to sign a ‘QP Declaration’. This document states that IMPs have been manufactured according to standards of Good Manufacturing Practice (GMP) at least equivalent to those applied in the EU. Specifically, a QP must release or certify that each batch of a product whether IMP or a commercially approved drug for human use was produced according to EU Directives. Our EU sites have QPs named on our site licenses to ensure the efficient import and release of EU GMP compliant materials into all EU member states.
US-based companies intending to export drug products to the EU need to understand the role of a QP. All other EU GMP requirements should be prepared for inspections. Our QPs can guide you through the complex regulatory environment. They’re here to answer all your questions when preparing European clinical trial applications (CTAs).
The European Directive 2001/83/EC Article 51
The European Directive 2001/83/EC Article 51 defines the QP responsibilities.
“… the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with the laws in force in the member state where certification takes place, in accordance with the requirements of the marketing authorization (MA) with good manufacturing practice (GMP).”
Annex 16 of the EU Guidelines for GMP details the routine duties of the QP to ensure:
- Manufacturing has been carried out in accordance with GMP regulations
- Manufacturing and testing processes have been validated
Any changes in production or quality control have to be authorized by a Responsible Person. All necessary checks and tests will have been performed with all production and quality control documents completed and authorized.
All audits of manufacturing and testing facilities are carried out as required to ensure conformity with EU GMP.
Meeting the Most Rigorous Standards
Our knowledgeable team will ensure your clinical studies meet the most rigorous standards while running smoothly, seamlessly, and cost-effectively. Our QPs assume responsibility for all stages of the process, including auditing the supply chain for GMP compliance as well as the certification of products for use in clinical trials.
Cryoport Systems’ QPs also offer a consultancy service to ensure your operations are in line with all relevant EU directives and other necessary regulations. They can help with clinical trial design and bringing new products to market, ensuring that commercial products are launched in accordance with global regulatory requirements.
Cryoport Systems’ QP services include:
- Site audits (manufacturing & testing)
- Issuance of QP declaration
- Supply chain management
- Quality oversight
- Technical & manufacturing release
- Batch release
- Consulting services
Smooth transportation.
Our QP services can help expedite the smooth transportation of irreplaceable clinical and commercial samples across borders. Contact us to find out how we can help your organization.
