PETra in Mexico: Obtaining GMP certification in an expanding market
26/09/2024
Juan Carlos Manrique-Arias (left) with LabLogic’s Wayne Houston and Gavin Rowlett during an onsite IQ and OQ validation.
At a glance
> Auna – Latin America’s leading healthcare provider – is implementing LabLogic’s PETra at a radiopharmacy-cyclotron in Monterrey, Mexico.
> The LIMS is being used to manage the production of radiopharmaceuticals and obtain GMP certification.
> Radiopharmacy Manager Dr. Juan Carlos Manrique-Arias explains how PETra is allowing his facility to keep pace with regulators as nuclear medicine expands in this part of the world.
The expansion of nuclear medicine in Latin America
The leading healthcare provider in Spanish-speaking Latin America – Auna – is implementing LabLogic’s PETra at a cyclotron in Monterrey, Mexico, where a range of isotopes are produced to supply three high-complexity hospitals: OCA Hospital, Doctor’s Hospital, and Doctor’s Hospital East, as well as distribute doses to other PET centres. Dr. Juan Carlos Manrique-Arias is the site’s manager, where he oversees the production of many common medical radioisotopes such as 64Cu, 123I, 124I, 89Zr, 68Ga, 18F, 11C, and 13N.
As nuclear medicine expands in Latin America, regulators are keen for new and existing radiopharmacies to demonstrate proper compliance with GMP and other guidelines. Dr. Manrique outlined the challenges of managing radiopharmaceuticals production without a modern electronic system in an expanding market, and how this has changed with the use of PETra.
Doctor’s Hospital is one of three hospitals in Monterrey being supplied by Auna’s cyclotron where PETra is being used.
The principles of ALCOA
Ensuring data integrity is crucial in radiopharmaceutical production, particularly during GMP inspections, where regulatory bodies focus heavily on this aspect. In 2016, the FDA introduced the principles of ALCOA, stating that “complete, consistent, and accurate data should be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate.”
PETra is designed to meet these stringent requirements, incorporating features that align with ALCOA. Data integrity is provided through secure user authentication, comprehensive audit trails with full traceability, time-stamped entries, and strict instrument calibration management, ensuring that the correct processes are followed.
“… PETra ensures that we follow the correct processes …”
Juan Carlos said, “Before PETra, every single step of production, including inventory, quality control, and reporting was done manually, which is a lot of work. It was prone to human error and there was limited traceability. Data was managed using paper and Excel, with entries requiring multiple checks, but PETra ensures that we are now following the correct processes and allows us to easily demonstrate compliance to the authorities, with data integrity being one of the most challenging points before PETra.
“We have already been inspected by COFEPRIS [Federal Commission for Protection against Heath Risks]. Mexican authorities are digging deep into the details of a facility’s compliance with GMPs, so being able to use a system which is designed around those principles helps us improve the quality of our operations, which is very reassuring.”
“…we immediately recognised the software’s potential to manage production.”
One of the first things that stood out to Dr. Manrique was PETra’s inventory management module, which allows radioisotope producers to digitally track stock of raw materials and consumables, including automatic reminders when stock is low, using barcodes. This provides a comprehensive record of inventory from the ordering of materials to their release for use in radiopharmaceutcal production. It was this ability to pull historical records with a clear chain of custody that caught Juan Carlos’ attention who said, “After seeing the functionality of PETra’s inventory management, we immediately recognised the software’s potential to manage production. Subsequently, the traceability PETra has introduced to our facility has facilitated GMP certification.
“The nice thing about PETra is that at the end of production, it is quick and easy to create a batch record. Having everything in one batch production PDF – cyclotron, synthesis, QC, dispensing, and so forth – and being able to present that at the end is hugely beneficial. Before, we had to manually assemble all this information, which was lengthy and prone to error.”
“Implementing it has been in the best interests of the lab …”
Validating a new system can be challenging, but LabLogic has onboarded leading software solutions at hundreds of facilities around the world, and Auna was supported by onsite IQ, OQ and PQ visits from LabLogic’s PETra team. Juan Carlos said, “The support and availability of the team at LabLogic has been excellent. I’m delighted how the project has come together; it has been an excellent collaboration.
“My team are adapting to PETra but they now consider it to be a much nicer way of working. Implementing it has been in the best interests of the lab, and having all information stored in a secure single digital system is a huge asset.”
“PETra is a worthwhile investment.”
Summarising this change in working, Juan Carlos concluded, “I would advise any other site to use PETra because it definitely helps with GMP certification. In my experience, authorities in Latin America are becoming stricter and asking for improved data management, and thanks to this software, we can now supply that. Based on the improvements I have observed, I am already thinking of introducing it in another radiopharmacy that I manage within Auna; PETra is a worthwhile investment.
Find out more
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