Questionnaire for Organic Impurities Assessment

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Cynthia Schulz
Email: cynthia.schulz@gmp-publishing.com
Phone: +49 7622 66686-70

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In order to perform a toxicological evaluation and risk assessment of the organic impurity under review, its chemical structure should be provided. Furthermore, information on the product administration route, the maximum daily intake and the treatment duration should also be provided by the client.

Please note that this information is necessary for performing an accurate and reliable toxicological evaluation and risk assessment. The purpose of this questionnaire is to compile and interpret the results on both the impurity and the drug product. In this way, the conclusions extracted in the subsequent risk analysis will be reliable for regulatory purposes.

Regulatory Requirements:

Is the toxicological evaluation of the organic impurity required as part of a registration dossier?*:

Is it necessary to set a specification for the organic impurity in the finished product?*:

Does the impurity appear as an out of tendency or out of specification result?*:

Does a deficiency letter of a governmental agency exist in relation to the organic impurity, and if so, what are the requirements?*:

Impurity Description:

Impurity described in Pharmacopoeia (Ph. Eur, USP)*:

Impurity description:
Chemical name, CAS registry number, smile notation, molecular weight and molecular formula… (please specify if known)*:

Are there any internal preclinical tests performed? (either with the product containing the impurity or the isolated impurity, please specify if available):

Product Description:

Administration route of the pharmaceutical product*:

Maximum daily dose of the pharmaceutical product*:

Average treatment duration (Lifelong treatment, chronic exposure, short-term exposure, single administration)*:

Contact Details::

Company (for which the assessment should be issued)*:

Street No.*:

Post Code/City*:

First Name*:

Last Name*:

Email*:

Phone*:

Street (in case of different billing address):

Post Code/City (in case of different billing address):

Please enter these characters in the following text field.

The fields marked with * are required.

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Questionnaire for Organic Impurities Assessment

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