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Propsed USP Chapter | BioQuality.biz

Two new proposed USP chapters were presented and discussed at the recently-held AAPS National Biotechnology Conference. The proposed chapters are both numbered greater than 1000 and so are guidance, not mandatory, and will be of interest to biotechnology professionals.

Proposed USP <1106> was discussed in the previous post.

Proposed USP <1050.1>, meant to be a companion chapter to USP <1050>, addresses Design, Evaluation, and Characterization of Viral Clearance Procedures. According to moderator Robert Bell, Ph.D., from Drug and Biotechnology Development LLC, the purpose of the proposed chapter is to supplement <1050>, which is “long on philosophy, but short on details.” Topics discussed by him and co-moderators Jeri Ann Boose, Ph.D., from Lancaster Laboratories, and Ray Nims, Ph.D., from RMC Pharmaceutical Solutions, included:

  • A review of USP, the standard setting process, and expert committees
  • Background on existing Chapter <1050>
  • The scope of proposed <1050.1>
  • Experimental Design for viral clearance studies

To see the proposed chapters, go to the Pharmacopeial Forum website: www.usppf.com (access to Pharmacopeial Forum is free, after sign-up)

See this month’s BioQuality for a detailed discussion of this important new document. To subscribe: www.bioquality.biz

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