Perrigo: Pharmaceutical industry should question nitrosamine risk assessments

The pharmaceutical industry needs to closely evaluate suppliers’ testing to ensure that accurate methods are being used to assess nitrosamine risks in drug products. Not questioning dubious results can wreak havoc and unnecessarily flag high levels of impurities where none may exist, warned an official from Perrigo at a 31 August webinar.

The focus of the webinar, convened by the International Pharmaceutical Excipients Council (IPEC), focused on a set of best practices for assessing and detecting nitrosamines and how to work with suppliers in testing products for these potentially carcinogenic compounds while complying with FDA’s guidance calling for such testing, (RELATED: N-Nitrosamine impurities: FDA issues detection, prevention strategies Regulatory Focus, 1 September 2020)

Active pharmaceutical ingredients (APIs) as well as excipients need to be tested as they may contain nitrite and nitrosamine impurities, according to the guidance, which was prompted by a series of recalls that beginning in 2019 for blood pressure medicines which contained a high level of nitrosamine impurities.

The guidance advised manufacturers to assess the nitrosamine impurity risk associated with all approved or marketed drug products by 31 March 2021.

Get meaningful data

Jennifer Nette, the senior manager for analytical R&D for Perrigo, said that as industry embarks on these risk assessments and testing programs, it is critical to ensure they are obtaining “meaningful data” from these risk assessments.

“We need to be able to avoid and prevent the common set of testing issues and eliminated false positive results,” she said.

She related a recent case where one of their suppliers decided to outsource the testing of an excipient to a contract laboratory, as they had no in-house capabilities to test. The tests came back with a reportable amount that exceeded acceptable thresholds for each of the six nitrosamines tested.

The company initiated a “lot of dialogue” with the supplier and the contract lab to discuss the results. The contract lab reviewed their testing documents and findings and subsequently uncovered errors in the testing. The lab retested the samples and found the excipient was within acceptable limits.

”The takeaway is that if you suspect errors in the supplier’s information or the public domain you should communicate your concerns with the supplier,” said Nette. She added that “false positive data or poor data is always worse than no data. This puts a high burden on the user and the supplier.”

IPEC Americas webinar

Perrigo: Pharmaceutical industry should question nitrosamine risk assessments

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