In 21 CFR 211.194 (a)(2), equivalency might not be explicitly mentioned, but it's often inferred in terms of meeting regulatory standards. Regarding ICH Q5A(R2), while it allows the use of validated NGS methods without head-to-head comparison, compliance with US/EU regulations would depend on specific guidelines and interpretations by regulatory authorities. If its not clear, regulatory bodies can be consulted.
Original Message:
Sent: 28-Apr-2024 07:46
From: Anonymous Member
Subject: 21 CFR reference on compendial method replacements
This message was posted by a user wishing to remain anonymous
Hi Raushan,
Thank you so much for the reply, much appreciated.
Are you referring to 21 CFR 211.194 (a)(2)? I apologize for being blind, but I do not seem to see the part where it talks about equivalency.
ICH Q5A(R2) states that the applicant may use a validated NGS method for viral detection without head-to-head comparison with the compendial methods. The recommendation makes scientific sense, but it is consistent with regulations in the US/EU?
As a side note, USP <1226> states that verification is not required for basic compendial procedures such as pH measurements. It makes sense from a risk management perspective, but is it consistent with the 21 CFR 194 (a)(2) mandate that "suitability of all testing methods used shall be verified under actual conditions of use" (emphasis is mine) which the USP chapter itself cites?
Thank you again for your insights.
OP
Original Message:
Sent: 27-Apr-2024 15:17
From: Raushan Blake
Subject: 21 CFR reference on compendial method replacements
The requirement you're referring to is outlined in 21 CFR 211.194, which states that if a compendial method is not used, the method chosen should be validated and documented. Additionally, it mandates that if a compendial method exists but is not used, the sponsor should demonstrate equivalency to the compendial method. So, while it doesn't explicitly mention a "head-to-head" comparison, it does require a demonstration of equivalency when a non-compendial method is used instead of a compendial one. In the science of Regulatory Affairs, sometimes the interpretations can be critical.
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Raushan Blake
Regulatory Affairs Specialist
Cook Medical - ENTERPRISE
Ennis
Ireland
Original Message:
Sent: 26-Apr-2024 08:08
From: Anonymous Member
Subject: 21 CFR reference on compendial method replacements
This message was posted by a user wishing to remain anonymous
I remember reading a 21 CFR regulation stating that if a sponsor plans to use a non-compendial method when a compendial method is available, a head-to-head comparison should be included in the submission. I am not able to locate the citation any more. If my memory serves me well, what is the 21 CFR reference to the statement above?
Thank you for your assistance.