New FDA Draft Guidance on cGMP for Combination Products

GMP News No. 480

GMP News
15 October 2004
 

New FDA Draft Guidance on
cGMP for
Combination Products

 
Among the FDA publications of 29 September (see our GMP News of 30 September 2004), there was a Draft Guidance for Industry and FDA on CGMP for Combination Products.

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:

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

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:

If the Operating Manufacturing Control System is Part 820 (QS Regulation)

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

Carefully Consider These Specific CGMP Requirements

Title

Carefully Consider These Specific QS Requirements

Title

§ 211.84

Testing and approval or rejection of components, drug product containers, 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 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.
  
Author:
Sven Pommeranz
CONCEPT HEIDELBERG  

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