Producers of positron emission tomography (PET) drugs asked the US Food and Drug Administration (FDA) for guidance on validation of aseptic preparation during meetings to discuss new regulations. The FDA has responded with a question and answer document explaining the media fill process.
“The simulation process should duplicate the actual production process where the aseptic steps are conducted, from the set-up of the vial assemblies to the transfer of the bulk drug from the sterilising filter into the final containers that are ready for release”, the FDA wrote in its final guidance.
In the guidance the FDA explains why media fills are done, how they are designed, and how often they should be performed. The document also covers growth promotion testing, its role in PET drug production, and how it differs from a positive control.
Guidance is needed as some PET manufacturers are unfamiliar with the drug approval process they must now follow. After a two-year preparation period, plus a further six months of enforcement discretion, manufacturers of PET products must have submitted a drug application by mid-June.
“PET producers who are unable to submit a new or abbreviated new drug application (NDA or ANDA) by June 12…must find a new supplier”, the FDA wrote. The supplier must have submitted a NDA or ANDA and comply with current good manufacturing practices (cGMPs).
Producing PET products for clinical use under an investigational new drug application (IND) is also acceptable. All PET drug manufacturers must have an approved NDA or ANDA, or an effective IND, by December 2015.