FDA Final Rule on Combo Product CGMPs - New! | SkillsPlus International Info

Tuesday, January 22, 2013

FDA Final Rule on Combo Product CGMPs - New!

Fda (Photo credit: Wikipedia)

Hot off the press!

This final rule clarifies which CGMP requirements apply when drugs, devices, & biological products are combined to create combination products:

Current Good Manufacturing Practice Requirements for Combination Products - A Rule by the Food and Drug Administration on 01/22/2013

In a nutshell:

The FDA is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.

Disclaimer

The Leader in Compliance Training: FDA, CGMP, QSR, Exemptee, and Designated Representative training courses. Students love our interactive on-site training classes, and the convenience of our internet-based e-Learning courses. www.skillsplusinc.com

The views expressed in the posts and comments of this blog do not necessarily reflect SkillsPlus International Inc. They should be understood as the personal opinions of the author. They should not be construed as consulting advice. No information on this blog will be understood as official. All data and information provided on this site is for informational purposes only. Skillsplusinfo.blogspot.com makes no representations as to accuracy, completeness, currentness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use. All information is provided on an as-is basis.

Comment Policy

All readers are encouraged to leave comments. While all points of view are welcome, only comments that are courteous and on-topic will be posted. SkillsPlus International Inc. reserves the right to post comments at its discretion. Spam and comments endorsing commercial products or services will not be posted.

Participants on this blog are fully responsible for everything that they submit in their comments, and all posted comments are in the public domain.

Answering technical questions is outside the scope of this blog.

All images on this site are copyright protected under Federal Copyright Laws and are the exclusive property (intellectual and real) of this blog's owner, unless otherwise attributed. All rights are reserved.

Our Blog Pages

Tuesday, January 22, 2013