This morning IPEC host a Q&A session where the use of ‘IPEC Europe Nitrosamine Questionnaire’.
Any member of the community have experience with this tool? What’s the response from regulatory bodies on this questionnaire when used by a drug product manufactures?
Link to document HERE
Hi @Naiffer_Host Thanks for sharing the recording here, it was an interesting experience to hear IPEC Europe LIVE.
Attached herewith is the link to Risk Assessment Questionnaire from IPEC as was being discussed in the session, March 2021 version.
Per my experience this tool is still being evaluated and is in preliminary stages of Implementation, nevertheless its an excellent Insight into evaluating Risk Assessment strategies for Excipients.The challenge will be wrt how many Excipient suppliers will be able to support with the responses to these Queries…
Am awaiting response from IPEC regarding strategies on Risk Assessment wrt Primary Packaging Materials. Shall update once I hear from them, it was my question during the QnA, awaiting details. Also need to understand if apart from Risk Assessment aspects, are there any Formal methods , acceptance criteria as yet established wwrt Nitrosamine control in Pharmaceutical Excipients & Primary Packaging Materials.
Thanks once again for sharing the recording , I had access only to the slide deck.
@DAB Thanks for sharing the slides. May I suggest to post that question you raised at the end in the excipient category of the community. I believe it’s a really interesting questions, and curious what has been the use of this tool among members. ‘https://nitrosamines.usp.org/c/rootcauses/excipients/11’
Thankyou, have added the Questions to the proposed link.
Really curious how has been the acceptability by drug product manufacturers and regulators of this assessment tool. As you @DAB pointed out it is in the preliminary stages. Can we perform a comprehensive risk assessment with this information? Separately, Lhasa has been doing some work on building an excipient database that contains Nitrate content information, anybody using that as part of their assessment?
Hi Naiffer @Naiffer_Host
Will look into the IPEC document and revert back . Am a bit occupied till about mid July so might take some time but will be connected with you on this
Hello, so the IPEC questionnaire is not new… it was initially rolled out for IPEC - Europe (2021 I think) and went through a 4 version (updating with regulations and or published new learnings of root causes). It was updated to be “IPEC - Federation, version 1 Feb 2023” as it was recognized that more than just EU pharmaceutical companies were implementing the use of this questionnaire during raw material supplier qualification / on-boarding activities. There is also a similar word doc that can be downloaded for use with active pharmaceutical ingredients “APIC Questionnaire” from APIC.Cefic.org.