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 solution 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.
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LabLogic Systems has been supplying nucleonic instrumentation and scientific software since 1979 to pharmaceutical, agrochemical and contract research organisations, who use the company's products in their research and development activities.