Sunday, 28 April 2013

FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs

FDA has released a new guidance titled “Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination" (April 2013).

In the guidance, FDA stresses the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs. Beta-lactam antibiotics include the following five classes:
  •  penicillins (e.g., ampicillin, oxacillin) 
  • cephalosporins (e.g., cephalexin, cefaclor) 
  •  penems (e.g., imipenem, meropenem) 
  • carbacephems (e.g., loracarbef) 
  • monobactams (e.g., aztreonam)
In this guidance FDA also provides information regarding the relative health risk of cross-reactivity in the classes of sensitizing beta-lactams (including both penicillin and non-penicillin beta-lactams). FDA states that manufacturers generally should use separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.

According to the document:

"This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and non-penicillin beta-lactams). Finally, this guidance clarifies that manufacturers generally should utilize separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity."

For further details, see FDA.

Posted by Tim Sandle

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