Dedicated Facilities: FDA publishes Draft Guideline

The Code of Federal Regulations 21 CFR § 211.42(c) lays down that the manufacture, processing and packing of penicillin shall be performed in separate facilities, whereof "separate" doesn't necessarily means separate buildings. Isolation within one area can be sufficient. Moreover, paragraph § 211.46(d) requires that air-handling systems for the manufacture of penicillin shall be completely separated from that for other drug products.

In the draft guideline "Non-Penicillin Beta Lactam Risk Assessment: a CGMP Framework" (which both applies to the manufacture of APIs and medicinal products) recommendation is made for non-pencillin beta lactam antibiotics. The document should help manufacturers to evaluate whether separate facilities are necessary or not. 

Chapter 3 with the recommendations given by FDA is relatively short. The FDA expects from manufacturers to treat non-penicillin beta lactam-based products in regard to separation exactly like penicillin. The FDA recommends to establish sufficient measures on separation and control in order to avoid cross-contamination risks between

  • Beta lactam and non-beta lactam products
  • Non-penicillin beta lactams and other non-penicillin beta lactams (cross-reactivity risk)

For the manufacture of a specific class of non-penicillin-beta-lactams (e.g. the cephalosporin family), separate facilities and air handling systems are not mandatory. According to the FDA, production campaigning and cleaning may be sufficient.

Please also see the draft of the new guideline.

Author
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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