GMP News No. 480
15 October 2004
New FDA Draft Guidance on
FDA's Acting Commissioner, Dr Lester M. Crawford, had already announced measures to improve the handling of combination products (see our GMP News of 3 August 2004).
By 'combination products', the FDA understands therapeutics that combine drug products, biologics and/or medical devices.
The guidance is 8 pages long and includes 4 chapters:
The FDA sees considerable overlap between the different regulations that could concern combination products (21 CFR 210/211, 21 CFR 600-680, 21 CFR 820). The FDA considers it to be important that the companies' quality systems include the respective regulations. Apart from the quality systems, the FDA compares key GMP provisions for combination products in a table:
Table 1: Key Current Good Manufacturing Practice Provisions to Consider During and After Joining Together Co-packaged and Single-Entity Combination Products
The FDA recommends expressly that the firms in question should discuss CGMP issues with the Agency - if possible at a very early stage, like during development or pre-investigational meetings. Further information can be requested from the Office of Combination Products.
You can view the guidance if you click here.