JVT

Reader Q&A: Questions 21-24 | IVT

Several respondents have recommended current expectations for validated processes as a topic for further discussion. Some of the discussion points suggested by respondents have included: What is really meant by validation? What is really needed to demonstrate a reliable and consistent process? Why isn't the usual "three lot" approach to validation sufficient? What does FDA mean when they say that "three lots" doesn't tell the whole story on validation? Why is the validation group always asking for more—supporting documents, reports, rationales, justifications, plans, and so on? These points...

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