Blog

Annex 1 Draft Revision and Stakeholder Comment Period

Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients.

Although it has undergone periodic targeted updates, this is the first time it has undergone a complete review. Seemingly the current Annex 1 has not kept pace with current regulatory and technological advancements and so this thorough review was necessary. According to the European Commission “this revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow.” 

Key changes noted are:

  • Introduction of new sections
  • Introduction of QRM Principles
  • Restructured to give more logical flow
  • Added detail to a number of the previous sections to provide further clarity

IVT Network has been given an opportunity to represent you — the relevant stakeholders, in the second consultation. Further, IVT has agreed to receive all the comments of this second consultation from our members, to compile and return to the European Commission.

For more detail and explanation on the specific changes to Annex 1 and the expected impact on manufacture of sterile products please read our blog and watch for pending articles coming up in the March Journal of GXP Compliance.

In the meantime, you may download the Annex 1 revision documents and prepare your comments.

To better understand some historical data and the proposed changes that are included in the draft revision for comment listen to this insightful conversation with Dr. Tim Sandle:




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.

Comments (0)

Post new comment

The content of this field is kept private and will not be shown publicly.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
  • Use to create page breaks.
Image CAPTCHA
Enter the characters shown in the image.
Validation Master Plan Download banner