Guidance for Industry on the Topic of Cross-Contamination

The topic cross-contamination is very important in the GMP environment. For example, Chapter 5 of the EU GMP Guide was adapted in this regard a few years ago. Annex 15 also paid more attention to the topic with the 2015 revision. The topic is also important for the FDA, especially when it comes to penicillins. However, the FDA also considers non-penicillin beta-lactam medicinal products to be critical with regard to cross-contamination and has therefore published a draft document on this.

The draft document entitled "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination" comprises 15 pages including two appendices. The table of contents reads as follows:

  • Introduction ´
  • Background (with references to the regulatory framework and beta-lactam components) 
  • Recommendations (with references to non-penicillin beta-lactam antibacterial drugs and non-antibacterial beta-lactam mixtures) 
  • Glossary of terms 
  • References 
  • Appendix A (chemical structures) 
  • Appendix B (Design features and controls to prevent cross-contamination)

The draft document is intended to replace an industry guideline from 2013 with the same title. The aim of the guideline is to provide guidance on methods, design requirements for premises and control elements to prevent cross-contamination with components carrying a beta-lactam ring.

Of particular interest from a GMP perspective is Appendix B, which describes design requirements and measures to prevent cross-contamination. Material compositions (liquid/solid), the manufacturing process (incoming inspection, mixing) and dosage forms are to be considered. Examples of design options and organisational measures to prevent cross-contamination are described on 15 bullet points. This ranges from the recommendation of closed systems, dedicated facilities and ventilation systems to the risk assessment of changes in the manufacturing process or in products or when introducing new products.

You can find the draft document on the FDA website.

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