Question

ICH Q7 Guidelines

6 months ago

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4 Replies

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496 views

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Mehboob 97

What are the basic ICH Q7 guidelines for handling reference standards?

4 Replies

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Mehboob 97 Best Answer!

Thank you, Joseph and Junal for you your contribution. Looking forward to your support in the future as well.

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Junal Best Answer!

Yeah right, Joseph.


These guidelines are about how you can keep the record and be organized in every step of the process. Check out the shared resource to have a detailed explanation about sections 11.17, 11.18, 11.19 of ICH Q7 for handling primary and secondary reference standards

M
Mehboob 97 Best Answer!

Joseph, Thank you for sharing this information. Appreciate it.

Joseph B Profile Picture
Joseph B Best Answer!

Verified Sherpa Tutor

By no means my area of expertise, but I would think this is what you're after:

Primary reference standards should be obtained as appropriate for the manufacture of APIs. The source of each primary reference standard should be documented. Records should be maintained of each primary reference standard’s storage and use in accordance with the supplier’s recommendations. Primary reference standards obtained from an officially recognised source are normally used without testing if stored under conditions consistent with the supplier’s recommendations.

from Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients (europa.eu) (section 11.17; see also glossary at the end)

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