The API manufacture process presents many challenges for you to overcome
A Qualified Person assumes personal responsibility for certifying each batch of material prior to release into EU, EEA or UK clinical trials.
Named on the Manufacturer’s and Importer’s License, their certification legally confirms that materials have been manufactured in full compliance with GMP and all relevant EU regulation, along with the Clinical Trial Application and Product Specification File.
QP Qualifications
A QP must have qualifications in Chemistry, Pharmacy or Microbiology. They must also have wide ranging technical knowledge and experience within the pharmaceutical industry.
Access to an appropriately qualified, in-house QP resource isn’t achievable for most sponsors, which is why many choose to outsource this highly specialist function to experts like us. Widely known and respected, our QPs have experience across a wide range of product types and dosage forms, while our highly experienced support team can assist you in the release of IMPs for use in clinical trials, including importation into the EU.
Why choose Almac?
If you’re looking for QP Services that deliver full compliance and provide expert support at every step of the process, look no further. We recognise that QP requirements can be a complex task to get to grips with, which is why we offer easy-to-follow release procedures that provide you with a consistent, secure, and structured approach that has been repeatedly reviewed during MHRA inspections. It’s also the reason behind our QP Facilitation Program, an on-site initiative that simplifies and expedites the QP release process.
We know that the evolving regulatory landscape can make keeping up to date with your precise compliance obligations difficult. That’s why our highly skilled experts proactively ensure continued compliance by providing you with up to the second information on regulatory guidance and expectations.
And when it comes to importing clinical supply into the EU, our global auditing of third-party manufacturing, testing, packaging, and labelling facilities (delivered on site or via our virtual auditing solution) safeguards compliance, while keeping your vital clinical trial timelines on track.
Olive McCormick
Director of Quality
“Qualified Person requirements are often viewed as a minefield by many sponsors. I Supply With Care because it matters to me that our clients feel confident taking on the challenge and have all the knowledge and support they need to excel.
I Supply With Care because by educating and mentoring clients in the requirements of EU legislation, and by performing audits of manufacturing, testing, and packaging sites all over the world, we champion compliance and patient safety.”
Changes to the Annex 1 Requirements
Understanding how the Annex 1 changes impact customers and knowledge on industry expectations in regard to key areas. Register below to view a video explaining the changes
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