Understanding the Essential Role of a Qualified Person
Sentry Biopharma’s QP can provide batch certification for importation of drug products into the EU as well as audit pharma manufacturing and storage facilities.
If you are a company planning to import drug products into the European Union (EU) countries including Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden, it is essential to understand the role of a Qualified Person (QP).
What is a Qualified Person?
A QP is typically a licensed pharmacist, biologist, or chemist (or a person with similar qualifications) who has several years of experience working in pharmaceutical manufacturing activities and is a resident within the EU and contracted with a specific facility, explains Tim Mitchell, president and CEO of Sentry Biopharma Services ApS.
Essentially, the QP is responsible for certifying that each batch of a drug product manufactured outside of the EU which is to be imported into the EU complies with the Good Manufacturing Practices (GMP) expected in Europe.
Before certifying a drug product, a QP must review all relevant batch-specific data and have a comprehensive knowledge about the manufacturing company’s quality system and processes. According to Alex Mitchell, Director of Operations, this includes not only review of the company that manufactured the drug product into the dosage form, but also those that manufactured the Active Pharmaceutical Ingredient(s), and performed the testing, and packaging and labeling. The QP must verify GMP compliance of each facility by performing a personal onsite audit or by reviewing an audit conducted by a qualified third party.
Hiring a Contracted QP
Many small to medium sized biopharmaceutical companies do not have facilities in Europe and therefore do not have an onsite Qualified Person (QP) on staff hindering the import IMP into the European for clinical trials, Tim explains.
These companies require a contracted QP to perform release and declaration services to facilitate the importation of their pharmaceutical materials into the European Union (EU). Further importation of their materials into the United Kingdom (UK) has been complicated by Brexit. These companies often have limited regulatory expertise and lean on contract service providers to guide them through the regulatory processes.
Sentry’s QP Solution
A wholly owned subsidiary of Sentry BioPharma Services, Inc., Sentry BioPharma Services ApS (Sentry ApS), located in Copenhagen, Denmark is a contracted service provider for the storage and distribution of pharmaceutical products for manufacturing and clinical trials.
In addition to specializing in ultra-low temperature storage (-70°C to -90°C), Sentry ApS provides QP batch certification and declaration services for client material through an onsite Qualified Person (QP), says Alex. Sentry’s QP ensures that imported pharmaceutical products meet GMP manufacturing, storage, and supply chain regulations so they can be used in European clinical trials.
The QP also facilitates the export of these materials to countries within the European Union (EU) and outside of the EU as well as to the United Kingdom. Sentry’s QP can audit pharmaceutical manufacturing and storage facilities around the world as well as coordinate with other QP’s to expedite QP to QP agreements to expedite confirmation of GMP compliance, Alex adds.
The Sentry ApS QP in Denmark provides a regulatory path for client materials being stored in the US at Sentry Biopharma Services, Inc. to be imported to clinical sites located in the EU and UK. Given Sentry ApS’ regulatory, storage, and distribution experience of biopharmaceutical materials, clients can meet European Medicine Agency (EMA) regulations while ensuring the integrity of their pharmaceutical products is protected.
With Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) became the sole-decision maker regarding authorization of medicines in the UK, explains Alex. While the MHRA follows closely with many European Medicines Agency (EMA) regulations, the MHRA has a separate application process and regulations pertaining to investigational medicinal products (IMP) used in clinical trials.
The MHRA now requires sponsors (or their legal representatives) of clinical trials taking place in the UK to be resident of the UK or in a country included in the MHRA’s approved country list, which includes the EU and EEA countries. As a result, sponsors of clinical trials being conducted during Brexit transition had to adjust mid-stream to ensure the residency requirements were met.
Going forward, sponsors will need to build partnerships and agreements with pharma organizations in the EU/EEA as well as UK based importation and distribution hubs that can ensure residency requirements are met.
For more information, go to: https://sentrybioaps.com/