PDG (Pharmacopoeial Discussion Group) Sign-off Cover Sheets (which provide information such as on harmonized provisions, non-harmonized provisions, and local requirements as well as the signatures of three pharmacopoeias) on the harmonized general chapters are listed. From the sign-offs on December 22, 2020, not only sign-off cover sheets but full texts of the harmonized documents are published. (See the PDG November 2020 Videoconference Meeting Highlights.)
The JP edition or supplement of each implementation date is shown in the table “Implementation date of JP Editions and Supplements”
As of November 23, 2023
| Harmonization Item | JP General Test /General Information |
Sign-off | Implementation |
|---|---|---|---|
| Q-01 / Dissolution | <6.10> Dissolution Test | ||
| Signed-off | June 22, 2004 | April 1, 2006 | |
| Rev. 1 | November 8, 2005 | - | |
| Rev. 2 | November 12, 2008 | July 30, 2010 | |
| Rev. 3 | June 10, 2010 | October 1, 2010 | |
| Rev. 3, Corr. Sign-off cover sheet | October 3, 2018 | - | |
| Rev. 3, Corr. Sign-off cover sheet | October 2, 2019 | - | |
| Rev. 5 | |||
| Q-02 / Disintegration | <6.09> Disintegration Test | ||
| Signed-off | June 21, 2004 | April 1, 2006 | |
| Rev. 1 | October 30, 2007 | March 31, 2009 | |
| Rev. 1, Corr.1 | October 3, 2018 | - | |
| Rev. 2 | |||
| Q-03/04 / Uniformity of Content/Mass | <6.02> Uniformity of Dosage Units | ||
| Signed-off | February 18, 2004 | April 1, 2006 | |
| Rev. 1 | November 9, 2010 | May 31, 2013 | |
| Rev. 1, Revised Sign-off cover sheet | June 15, 2011 | - | |
| Rev. 1, Rev. of Sign-off cover sheet | November 6, 2013 | - | |
| Rev. 2 | November 4, 2015 | December 1, 2017 | |
| Rev. 2, Corr. 1 | October 26, 2016 | - | |
| Q-05a / Tests for Specified Microorganism | <4.05> Microbiological Examination of Non-sterile Products | ||
| Signed-off | November 8, 2005 | October 1, 2007 | |
| Rev. 1 | June 5, 2008 | Mach 31, 2009 | |
| Q-05b / Microbial Enumeration | <4.05> Microbiological Examination of Non-sterile Products | ||
| Signed-off | November 8, 2005 | October 1, 2007 | |
| Rev. 1 | June 5, 2008 | March 31, 2009 | |
| Rev. 1, Corr. 1 | June 10, 2009 | April 1, 2011 | |
| Rev. 1, Corr. 2 | August 22, 2023 | (April, 2026) | |
| Q-05c / Limits for Non-sterile Products | <G4-1-170> Microbial Attributes of Non-sterile Pharmaceutical Products | ||
| Signed-off | November 8, 2005 | October 1, 2007 | |
| Rev. of Sign-off cover sheet | June 27, 2013 | - | |
| Corr. of Sign-off cover sheet | October 3, 2018 | - | |
| Q-06 / Bacterial Endotoxins | <4.01> Bacterial Endotoxins Test | ||
| Signed-off | January 3, 2000 | April 1, 2011 | |
| Rev. 1 | November 11, 2008 | April 1, 2011 | |
| Rev. 1, Corr. 1 | October 27, 2009 | April 1, 2011 | |
| Rev. 2 | June 15, 2011 | October 1, 2012 | |
| Q-07 / Color (instrumental method) | <G1-4-181> Instrumental Measurement of Coloration of Liquids | ||
| Signed-off | October 26, 2016 | - | |
| Rev. 1 | June 24, 2019 | December 12, 2022 | |
| Q-08 / Extractable Volume | <6.05> Test for Extractable Volume of Parenteral Preparations | ||
| Signed-off | July 18, 2000 | - | |
| Rev. 1 | June 10, 2004 | July 21, 2005 | |
| Update to Rev. 1, Sign-off cover sheet | November 9, 2010 | - | |
| Rev. 2 | |||
| Q-09 / Particulate Contamination | <6.07> Insoluble Particulate Matter Test for Injections | ||
| Signed-off | May 21, 2001 | - | |
| Rev. 1 | June 10, 2004 | April 1, 2006 | |
| Rev. 1, Sign-off cover sheet | November 9, 2010 | April 1, 2011 | |
| Update to Rev. 1, Sign-off cover sheet | June 6, 2012 | - | |
| Rev. 2 | |||
| Q-10 / Residue on Ignition | <2.44> Residue on Ignition Test | ||
| Signed-off | February. 11, 2000 | January 1, 2003 | |
| Rev. 1 | September 10, 2002 | January 1, 2005 | |
| Rev. 2 | August 4, 2005 | April 1, 2006 | |
| Q-11 / Sterility Test | <4.06> Sterility Test | ||
| Signed-off | September 10, 2002 | January 1, 2005 | |
| Rev. 1 | October 30, 2007 | March 31, 2009 | |
| Rev. 1, Corr. 1 | June 3, 2008 | March 31, 2009 | |
| Rev. 1, Corr. 2 | November 11, 2008 | - | |
| Rev. 1, Corr. 3 | June 10, 2009 | April 1, 2011 | |
| G-01 / Analytical Sieving | <3.04> Particle Size Determination | ||
| Signed-off | June 10, 2004 | April 1, 2006 | |
| Rev. 1 | May 8, 2007 | October 1, 2009 | |
| Rev. 1, Corr. 1 | November 15, 2021 | December 12, 2022 | |
| Rev. 2 | |||
| G-02 / Bulk Density of Powders | <3.01> Determination of Bulk and Tapped Densities | ||
| Signed-off | May 8, 2007 | October 1, 2009 | |
| Rev. 1 | June 5, 2008 | October 1, 2009 | |
| Rev. 1, Corr. 1 | June 10, 2009 | April 1, 2011 | |
| Rev. 2 | June 15, 2011 | October 1, 2012 | |
| Rev. 3 | November 6, 2013 | October 1, 2012 | |
| Rev. 4 | January 20, 2023 | (June, 2024) | |
| Rev. 4, Corr. 1 | November 24, 2023 | (June, 2024) | |
| G-03 / Conductivity | <2.51> Conductivity Measurement | ||
| Signed-off | September 13, 2017 | June 28, 2019 | |
| Corr. 1 | October 2, 2019 | June 7, 2021 | |
| G-04 / Gas Pycnometric Density of Solids | <3.03> Powder Particle Density Determination | ||
| Signed-off | May 8, 2007 | October 1, 2009 | |
| G-05 / Powder Flow | <G2-3-171> Powder Flow | ||
| Signed-off | June 10, 2004 | April 1, 2006 | |
| Rev. 1 | January 20, 2023 | (June, 2024) | |
| G-06 / Tablet Friability | <G6-5-181> Tablet Friability Test | ||
| Signed-off | February 18, 2004 | April 1, 2006 | |
| Rev. 1 | June 7, 2022 | December 12, 2022 | |
| G-07 / Elemental Impurities | (Harmonization work in progress) | ||
| G-09 / Optical Microscopy | <3.04>Particle Size Determination | ||
| Signed-off | June 10, 2004 | April 1, 2006 | |
| Rev. 1 | |||
| G-10 / Powder Fineness | <G2-2-171> Powder Fineness | ||
| Signed-off | May 8, 2007 | October 1, 2009 | |
| G-11 / Specific Surface Area | <3.02> Specific Surface Area by Gas Adsorption | ||
| Signed-off | November 10, 2003 | April 1, 2006 | |
| G-13 / Laser Diffraction Measurement of Particle size | <3.06> Laser Diffraction Measurement of Particle Size | ||
| Signed-off | November 11, 2008 | December 1, 2017 | |
| Rev. 1 | |||
| G-14 / X-Ray Powder Diffraction | <2.58> X-Ray Powder Diffraction Method | ||
| Signed-off | October 30, 2007 | April 1, 2011 | |
| Rev. 1 | December 22, 2020 | December 12, 2022 | |
| G-15 / Water-solid Interaction | <3.05> Water-Solid Interactions: Determination of Sorption- Desorption Isotherms and of Water Activity | ||
| Signed-off | October 27, 2009 | October 1, 2012 | |
| G-16 / Thermal Analysis | <2.52> Thermal Analysis | ||
| Signed-off | June 26, 2014 | April 1, 2016 | |
| Rev. 1 | |||
| G-20 / Chromatography | <2.00> Chromatography | ||
| Signed-off | September 28, 2021 | December 12, 2022 | |
| Corr. 1 | November 13, 2023 | ||
| Rev. 1 | |||
| G-21 / Dynamic Light Scattering | (JP draft under development) | ||
| Signed-off | March 14, 2023 | (June, 2024) | |
| Corr. 1 | June 14, 2023 | (June, 2024) | |
| B-01 / Amino Acid Determination | <G3-2-171> Amino Acid Analysis | ||
| Signed-off | September 9, 2002 | January 1, 2005 | |
| Rev. 1 | October 26, 2016 | December 1, 2017 | |
| B-02 / Capillary Electrophoresis | <G3-7-180> Capillary Electrophoresis | ||
| Signed-off | September 10, 2002 | January 1, 2005 | |
| Corr. 1 | October 27, 2009 | - | |
| Corr. 2 | June 9, 2010 | July 20, 2010 | |
| Corr. 3 | November 20, 2018 | June 7, 2021 | |
| Rev. 1 | |||
| B-03 / Isoelectric Focusing | <G3-6-142> Isoelectric Focusing | ||
| Signed-off | September 9, 2002 | January 1, 2005 | |
| B-05 / Peptide Mapping | <G3-3-142> Peptide Mapping | ||
| Signed-off | September 10, 2002 | January 1, 2005 | |
| Rev. 1 | January 20, 2023 | (June, 2024) | |
| B-06 / Polyacrylamide Gel Electrophoresis | <G3-8-170> SDS-Polyacrylamide Gel Electrophoresis | ||
| Signed-off | October 15, 1999 | January 1, 2003 | |
| Rev. 1 | June 26, 2014 | April 1, 2016 |
Following six items were suppressed from the PDG work programme in September, 2017. (Please also see the PDG September 2017 Rockville Meeting Highlights.)
| Harmonization Item | JP General Test /General Information |
Sign-off | Implementation |
|---|---|---|---|
| G-08 / Inhalation | - | - | |
| G-12 / Porosimetry by Mercury Intrusion | May 8, 2007 | - | |
| G-17 / Uniformity of Delivered Dose of Inhalations | - | - | |
| G-18 / Microcalorimetry | June 15, 2011 | - | |
| G-19 / Density of Solids | - | - | |
| B-04 / Protein Determination | <G3-12-172> Total Protein Assay | September 10, 2002 | - |