FDA Issues Draft Guidance on Contract Manufacturing at (www.pharmtech.com)

Posted on

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

May 28, 2013
By: Patricia Van Arnum
FDA has issued draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which describes the agency’s current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in contract cGMP manufacturing of drugs.

READ ALL AT

http://www.pharmtech.com/pharmtech/News/FDA-Issues-Draft-Guidance-on-Contract-Manufacturin/ArticleStandard/Article/detail/814272?contextCategoryId=48563

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s