DMF section 3.2.S.5 - Reference standards

The DMF in CTD format consists of 7 sections. In this video we will talk about section 3.2.S.5, which is about the reference standards and materials.

Standards are used both for the quality control analysis and for the analytical validations which were described in the previous section. Within the validation reports, the batches of standards that were used must have been informed.

Any batch of standard for the API or impurities used in such validations must be well characterized, because we need to be sure of their structure.
The ICH Q2 definition states that the reference material used in the validations must be a suitably characterized material, which may include national and international reference standards, pharmacopoeial reference standards, or in-house materials.

In case it is a pharmacopoeial standard, the certificate issued by the pharmacopoeia is sufficient proof of its quality, but in case it is an in-house standard, it will be necessary to present not only the certificate of analysis, but also some data that ensure its identity - for example infrared spectra, NMR and mass spectra.

In this section of the DMF, we will usually see the updated certificates for standards of the API and each of the impurities.

When these refer to batches that were used in analytical validations, it's important to pay attention to the expiry or retest date on their certificates, to ensure that they were valid at the time of the analytical validation where they were used.

But in general, this is a very simple and straightforward chapter of the DMF.

And this is all for section 3.2.S.5.
The next video will be about section 3.2.S.6, which is about the container closure system - the packaging - of the API.
Stay tuned!

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