JVT

Regulatory Actions Taken in Response To Issues in Aseptic Processing And The Quality System

FDA has cited many issues with the requirements in 21CFR 211.113(b), which sites failures in appropriate written procedures to prevent microbiological contamination. This requirement is as follows: Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21CFR 211.113(b)). Examples of FDA Concerns Poor Aseptic Behavior The operators displayed poor aseptic practices during aseptic set-up and filling operations. Examples of...

This content is only available to IVT members.
Get help maintaining your knowledge . 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.