GXP

Method Validation Studies—How GLP Interacts With Guidance Documents | IVT

This discussion addresses the need for analytical method validation in good laboratory practice (GLP) studies including stability studies Regulations clearly state that stability studies must be done and completed no later than the end of the GLP study.  Responsibility for appropriateness of testing and completion of stability studies rests with test facility management. Stability of test mixtures containing active drugs with carriers is specifically addressed.  Stability of the active drug alone does not answer this concern. GLPs apply to chemical procedures used to characterize the...

This content is only available to IVT members.
Get help maintaining your knowledge in GLP. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.