The New USP Chapter 1223: An Overview in Two Publications

On June 1, 2015, a substantially modified USP chapter <1223>, Validation of Alternative Microbiological Methods, was published in the second supplement to USP38/NF33 with an official date of 1st December 2015. Two recently published papers provide an overview of the chapter's most notable changes and compare the revision with what is recommended in the Parenteral Drug Association (PDA) Technical Report Number 33 and the proposed revision to European Pharmacopoeia (Ph. Eur.) chapter 5.1.6.

Both papers, authored by rapid methods expert Dr. Michael J. Miller, are referenced below and contain links to view the articles in their entirety.

2015. Miller, M.J. A Fresh Look at USP <1223> Validation of Alternative Microbiological Methods and How the Revised Chapter Compares with PDA TR33 and the Proposed Revision to Ph. Eur. 5.1.6. American Pharmaceutical Review. 18(5): 22-35.

2015. Miller, M.J. Rapid Methods Update: Revisions to a United States Pharmacopeia Chapter. European Pharmaceutical Review. 20(4): 38-43.