Harmonization Status for Biotechnology

Please see recent Pharmacopeial Discussion Group Working Procedures Changes here effective April 1, 2018.

 

The following table summarizes the sign-off and stage 4 posting status for all monographs and general chapters under the Pharmacopeial Discussion Group (PDG) work plan. Please note the Stage 4 postings appeared in PF prior to 2011 and Effective April 1, 2018, PDG will utilize a reduced 5-stage approach for harmonization. These tables will be updated whenever a new Stage 4 is posted.

There are four categories of postings in the table column of Stage 4 Web* Posting Date(s):

  • If the Stage 4 is posted on the USP website with a history, it will link to the most recent web posting.
  • If the Stage 4 is posted on the USP website with no history, the most recent posting is updated with PDG sign-offs and Stage 4 postings, when available.
  • If the Stage 4 was published in Pharmacopeial Forum (PF) previously with no web postings at all, a new web page is created for that monograph with a summary of previous PDG sign-offs and PF postings, when available.
  • If the monograph has not been signed off, it is labeled “N/A."

*Prior to 2011, the Stage 6 appeared in PF. Effective April 1, 2018, PDG will utilize a reduced 5-stage approach for harmonization.

USP Harmonization Status for Biotechnology (as of 27-Apr-2018)
PDG# Method Name CP PDG Current Official Harmonization Sign-off Status Stage 4 Web* Posting
Date(s)
B01 Amino Acid Determination <1052> USP S6
(28-Apr-2017)
Link to posting and signoff history
B02 Capillary Electrophoresis <1053> EP S6, Cor.2
(09-Jun-2010)
Link to posting and signoff history
B03 Isoelectric Focusing <1054> EP S6
(09-Sep-2002)
Link to posting and signoff history
B04 Protein Determination <1057> USP Suppressed from the PDG workplan. See the September 2017 PDG meeting highlights. Link to posting and signoff history
B05 Peptide Mapping <1055> USP S6
(10-Sep-2002)
Link to posting and signoff history
B06 Polyacrylamide Gel Electrophoresis <1056> EP S6, Rev.1
(2014.06.26)
Stage 6, 21–Nov–2014