New FDA Draft Guidance on cGMP for Combination Products

GMP News No. 480

15 October 2004

New FDA Draft Guidance on
cGMP for
Combination Products

Among the FDA publications of 29 September (see our GMPNews of 30 September 2004), there was a Draft Guidance for Industry andFDA on CGMP for Combination Products.

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:

  • Introduction
  • Background information
  • CGMP
  • Communication with FDA during development of a combination product

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:

If the Operating Manufacturing Control System is Part 820 (QSRegulation)

If the Operating Manufacturing Control System is Part 210/211(CGMP Regulation)

Carefully Consider These Specific CGMP Requirements


Carefully Consider These Specific QS Requirements


§ 211.84

Testing and approval or rejection of components, drug productcontainers, and closures

§ 820.30

Design controls

§ 211.103

Calculation of yield

§ 820.50

Purchasing controls

§ 211.137

Expiration dating

§ 820.100

Corrective and preventative actions

§ 211.165

Testing and release for distribution


§ 211.166

Stability testing


§ 211.167

Special testing requirements


§ 211.170

Reserve samples


* Including all subsections, as appropriate. 

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.
Sven Pommeranz


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