At the Society of Nuclear Medicine Annual Meeting, Lablogic Systems will show how its PETra LIMS can ensure batch records for PET radiopharmaceuticals comply with new FDA regulations by the deadline.
From 12 December a PET radiopharmaceutical producer must maintain master production and control records: complete and detailed written documentation for each product, covering methods used, QC tests performed and acceptance criteria.
For every product batch, the producer must maintain batch records, recording and documenting every production and QC process and comparing results of these processes and tests against the documented acceptance criteria for the product.
Any process deviations must also be recorded and each batch record should include full details of the analyst, time and date for every procedure.
A producer should also maintain detailed standard operating procedures (SOPs) regarding each production or QC process so that they can be referred to in master production and control records.
Furthermore, there should be full traceability of all raw materials used in production, and documented controls to demonstrate that raw materials are of sufficient quality and maintained in adequate stock levels.
Lablogic's PETra is a complete process management system that ensures compliance with these and the many other requirements for PET radiopharmaceutical producers set out in the forthcoming FDA CFR part 212 regulations and the amendments to USP 823.
