Chemistry

>

KS3

Classifying Materials

Question

ICH Q7 Guidelines

2 years ago

·

4 Replies

·

1354 views

M

Mehboob 97

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

4 Answers

Joseph B Profile Picture
Joseph B Verified Sherpa Tutor ✓

Experienced teacher and examiner of Scottish & English qualifications

Best Answer!

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)

I'm available for 1:1 private online tuition!

Click here to view my profile and arrange a free introduction.
M
Mehboob 97

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

J
Junal

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

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

Think you can help?

More Chemistry KS3 Questions
Sherpa Badge

Need a KS3 Chemistry tutor?

Get started with a free online introductions with an experienced and qualified online tutor on Sherpa.

Find a KS3 Chemistry Tutor