GXP

Compliance Case Study #6 Process Validation Failure—Liquid Product Batch Size Increase | IVT

A case study involving a batch size increase for a liquid solution product is described The batch size increase was considered to be a relatively simple change because other similar products at the site were already manufactured at the same increased batch size and the equipment to be used was “identical” to other site equipment Manufacturing was started and the formulation ingredients did not dissolve in the product solution—The validation performance qualification was a failure.  Mixing in the tank was not sufficiently rigorous The supposedly identical tank did not have the same...

This content is only available to IVT members.
Get help maintaining your knowledge in GMP - Corrective & Preventative Action (CAPA). 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.