USP Draft of a newly proposed Chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products

In the Pharmacopeial Forum 39(4), the USP published the draft of chapter <1115> "Bioburden Control of Nonsterile Drug Substances and Products". In their briefing, the USP outlined:

"Microbial content in nonsterile products is controlled to a level consistent with patient safety. Use of excessive controls that would add complexity or cost without a commensurate safety benefit is not advantageous in terms of added value to either the patient or the manufacturer. Therefore, a pragmatic scientific approach to management of the microbial bioburden in nonsterile products requires consideration of patient risk and contamination control objectives to achieve a practical and appropriate level of risk management.

This chapter outlines a risk-based approach to the control of potential contamination in nonsterile product manufacturing. It provides information about microbial control considerations in product development, microbial control considerations in routine manufacturing, microbial control of drug substance manufacturing, equipment design and use considerations, personnel, the manufacturing environment, microbial assessment of nonsterile product manufacturing environments, active measures for microbial control, and overall management of a microbiological control program."

The draft provides, amongst others, a hierachy of non sterile products, sorted by their potential risk of microbiological contamination:

  • metered-dose and dry powder inhalants
  • nasal sprays
  • otics
  • vaginal suppositories
  • topicals
  • rectal suppositories
  • oral liquids (aqueous)
  • liquid-filled capsules
  • oral tablets and powder-filled capsules

The complete draft can be found in the Pharmacopoeial Forum.

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