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GMP News No. 480
15 October 2004
New FDA Draft Guidance on
FDA's Acting Commissioner, Dr Lester M. Crawford, had already announcedmeasures to improve the handling of combination products (seeour GMPNews of 3 August2004).
By 'combination products', the FDA understands therapeutics thatcombine 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 regulationsthat could concern combination products (21 CFR 210/211, 21 CFR 600-680, 21 CFR820). The FDA considers it to be important that the companies' quality systemsinclude the respective regulations. Apart from the quality systems, the FDAcompares key GMP provisions for combination products in a table:
Table 1: Key Current Good Manufacturing Practice Provisions toConsider During and After Joining Together Co-packaged and Single-EntityCombination Products
The FDA recommends expressly that the firms in question should discussCGMP issues with the Agency - if possible at a very early stage, likeduring development or pre-investigational meetings. Further informationcan be requested from the Office of Combination Products.
You can view the guidance if you click here.