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[119KB].)
The JP edition or supplement of each implementation date is shown in the table “Implementation date of JP Editions and Supplements[23.4KB]”
As of June 19, 2024
General Methods relevant to Q6A
-
Q-01 / Dissolution <6.10> Dissolution Test
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | June 22, 2004[131KB] | April 1, 2006 |
| Rev. 1 | November 8, 2005[132KB] | - |
| Rev. 2 | November 12, 2008[61.6KB] | July 30, 2010 |
| Rev. 3 | June 10, 2010[53.2KB] | October 1, 2010 |
| Rev. 3, Corr. Sign-off cover sheet | October 3, 2018[452KB] | - |
| Rev. 3, Corr. Sign-off cover sheet | October 2, 2019[29.0KB] | - |
| Rev. 5 | (Stage 2) |
-
Q-02 / Disintegration <6.09> Disintegration Test
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | June 21, 2004[20.8KB] | April 1, 2006 |
| Rev. 1 | October 30, 2007[85.1KB] | March 31, 2009 |
| Rev. 1, Corr.1 | October 3, 2018[291KB] | - |
| Rev. 2 | (Stage 2) |
-
Q-03/04 / Uniformity of Content/Mass <6.02> Uniformity of Dosage Units
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | February 18, 2004[88.3KB] | April 1, 2006 |
| Rev. 1 | November 9, 2010[51.1KB] | May 31, 2013 |
| Rev. 1, Revised Sign-off cover sheet | June 15, 2011[64.0KB] | - |
| Rev. 1, Rev. of Sign-off cover sheet | November 6, 2013[481KB] | - |
| Rev. 2 | November 4, 2015[394KB] | December. 1, 2017 |
| Rev. 2, Corr. 1 | October 26, 2016[436KB] | - |
-
Q-05a / Tests for Specified Microorganism <4.05> Microbiological Examination of Non-sterile Products
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | November 8, 2005[86.7KB] | October 1, 2007 |
| Rev. 1 | June 5, 2008[25.9KB] | March 31, 2009 |
-
Q-05b / Microbial Enumeration <4.05> Microbiological Examination of Non-sterile Products
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | November 8, 2005[87.1KB] | October 1, 2007 |
| Rev. 1 | June 5, 2008[26.0KB] | March 31, 2009 |
| Rev. 1, Corr. 1 | June 10, 2009[21.9KB] | April 1, 2011 |
| Rev. 1, Corr. 2 | August 22, 2023[547KB] | (April , 2026) |
-
Q-05c / Limits for Non-sterile Products <G4-1-170> Microbial Attributes of Non-sterile Pharmaceutical Products
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | November 8, 2005[143KB] | October 1, 2007 |
| Rev. of Sign-off cover sheet | June 27, 2013[36.1KB] | - |
| Corr. of Sign-off cover sheet | October 3, 2018[358KB] | - |
-
Q-06 / Bacterial Endotoxins <4.01> Bacterial Endotoxins Test
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | January 3, 2000[116KB] | April 1, 2001 |
| Rev. 1 | November 11, 2008[27.3KB] | April 1, 2011 |
| Rev. 1, Corr. 1 | October 27, 2009[52.4KB] | April 1, 2011 |
| Rev. 2 | June 15, 2011[38.3KB] | October 1, 2012 |
-
Q-07 / Color (instrumental method) <G1-4-181> Instrumental Measurement of Coloration of Liquids
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | October 26, 2016[458KB] | - |
| Rev. 1 | June 24, 2019[42.1KB] | December 12, 2022 |
-
Q-08 / Extractable Volume <6.05> Test for Extractable Volume of Parenteral Preparations
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | July 18, 2000[31.3KB] | - |
| Rev. 1 | June 10, 2004[93.2KB] | July 21, 2005 |
| Update to Rev. 1, Sign-off cover sheet | November 9, 2010[48.9KB] | - |
| Rev. 2 | (Stage 2) |
-
Q-09 / Particulate Contamination <6.07> Insoluble Particulate Matter Test for Injections
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | May 21, 2001[31.2KB] | - |
| Rev. 1 | June 10, 2004[91.9KB] | April 1, 2006 |
| Rev. 1, Sign-off cover sheet | November 9, 2010[116KB] | April 1, 2011 |
| Update to Rev. 1, Sign-off cover sheet | June 6, 2012[108KB] | - |
| Rev. 2 | (Stage 3A) |
-
Q-10 / Residue on Ignition <2.44> Residue on Ignition Test
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | February 11, 2000[28.1KB] | January 1, 2003 |
| Rev. 1 | September 10, 2002[27.3KB] | January 1, 2005 |
| Rev. 2 | August 4, 2005[152KB] | April 1, 2006 |
-
Q-11 / Sterility Test <4.06> Sterility Test
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | September 10, 2002[27.0KB] | January 1, 2005 |
| Rev. 1 | October 30, 2007[125KB] | March 31, 2009 |
| Rev. 1, Corr. 1 | June 3, 2008[27.3KB] | March 31, 2009 |
| Rev. 1, Corr. 2 | November 11, 2008[22.4KB] | - |
| Rev. 1, Corr. 3 | June 10, 2009[52.8KB] | April 1, 2011 |
General Chapters
-
G-01 / Analytical Sieving <3.04> Particle Size Determination
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | June 10, 2004[22.4KB] | April 1, 2006 |
| Rev. 1 | May 8, 2007[88.5KB] | October 1, 2009 |
| Rev. 1, Corr. 1 | November 15, 2021[254KB] | December 12, 2022 |
| Rev. 2 | (Stage 1) |
-
G-02 / Bulk Density of Powders <3.01> Determination of Bulk and Tapped Densities
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | May 8, 2007[85.9KB] | October 1, 2009 |
| Rev. 1 | June 5, 2008[26.6KB] | October 1, 2009 |
| Rev. 1, Corr. 1 | June 10, 2009[31.5KB] | April 1, 2011 |
| Rev. 2 | June 15, 2011[36.3KB] | October 1, 2012 |
| Rev. 3 | November 6, 2013[354KB] | October 1, 2012 |
| Rev. 4 | January 20, 2023[2.3MB] | June 28, 2024 |
| Rev. 4, Corr. 1 | November 24, 2023[315KB] | June 28, 2024 |
| Rev. 4, Corr. 2 | June 18, 2024[706KB] | June 28, 2024 |
-
G-03 / Conductivity <2.51> Conductivity Measurement
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | September 13, 2017[421KB] | June 28, 2019 |
| Corr. 1 | October 2, 2019[78.3KB] | June 7, 2021 |
-
G-04 / Gas Pycnometric Density of Solids <3.03> Powder Particle Density Determination
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | May 8, 2007[86.3KB] | October 1, 2009 |
-
G-05 / Powder Flow <G2-3-171> Powder Flow
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | June 10, 2004[83.6KB] | April 1, 2006 |
| Rev. 1 | January 20, 2023[2.9MB] | June 28, 2024 |
-
G-06 / Tablet Friability <G6-5-181> Tablet Friability Test
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | February 18, 2004[58.1KB] | April 1, 2006 |
| Rev. 1 | June 7, 2022[230KB] | December 12, 2022 |
| Rev. 1, sign-off cover sheet ver. 2 | May 24, 2024[308KB] | - |
-
G-07 / Elemental Impurities (JP draft under development)
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | June 19, 2024[472KB] | (April, 2026) |
-
G-09 / Optical Microscopy <3.04>Particle Size Determination
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | June 10, 2004[87.6KB] | April 1, 2006 |
| Rev. 1 | (Stage 1) |
-
G-10 / Powder Fineness <G2-2-171> Powder Fineness
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | May 8, 2007[87.0KB] | October. 1, 2009 |
-
G-11 / Specific Surface Area <3.02> Specific Surface Area by Gas Adsorption
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | November 10, 2003[94.7KB] | April 1, 2006 |
-
G-13 / Laser Diffraction Measurement of Particle size <3.06> Laser Diffraction Measurement of Particle Size
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | November 11, 2008[25.7KB] | December 1, 2017 |
| Rev. 1 | (Stage 2) |
-
G-14 / X-Ray Powder Diffraction <2.58> X-Ray Powder Diffraction Method
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | October 30, 2007[199KB] | April 1, 2011 |
| Rev. 1 | December 22, 2020[672KB] | December 12, 2022 |
-
G-15 / Water-solid Interaction <3.05> Water-Solid Interactions: Determination of Sorption- Desorption Isotherms and of Water Activity
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | October 27, 2009[25.9KB] | October 1, 2012 |
-
G-16 / Thermal Analysis <2.52> Thermal Analysis
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | June 26, 2014[41.2KB] | April 1, 2016 |
| Rev. 1 | (Stage 1) |
-
G-20 / Chromatography <2.00> Chromatography
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off (Note 1) | September. 28, 2021[959KB] | December 12, 2022 |
| Corr. 1 | November 13, 2023[13.1MB] | |
| Rev. 1 |
Note 1: the Briefing Note for the General Test [580KB](September, 2021)
-
G-21 / Dynamic Light Scattering <3.07> Measurement of the Diameter of Particles Dispersed in Liquid by Dynamic Light Scattering
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | March 14, 2023[262KB] | June 28, 2024 |
| Corr. 1 | June 14, 2023[228KB] | June 28, 2024 |
Methods for Biotechnology Products
-
B-01 / Amino Acid Determination <G3-2-171> Amino Acid Analysis
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | September 9, 2002[96.6KB] | January 1, 2005 |
| Rev. 1 | October 26, 2016[22.0KB] | December 1, 2017 |
-
B-02 / Capillary Electrophoresis <G3-7-180> Capillary Electrophoresis
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | September 10, 2002[174KB] | January 1, 2005 |
| Corr. 1 | October 27, 2009[22.9KB] | - |
| Corr. 2 | June 9, 2010[31.5KB] | July 20, 2010 |
| Corr. 3 | November 20, 2018[50.4KB] | June 7, 2021 |
| Rev. 1 | (Stage 2) |
-
B-03 / Isoelectric Focusing <G3-6-142> Isoelectric Focusing
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | September 9, 2002[70.2KB] | January 1, 2005 |
-
B-05 / Peptide Mapping <G3-3-142> Peptide Mapping
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | September 10, 2002[93.7KB] | January 1, 2005 |
| Rev. 1 | January 20, 2023[5.4MB] | June 28, 2024 |
-
B-06 / Polyacrylamide Gel Electrophoresis <G3-8-170> SDS-Polyacrylamide Gel Electrophoresis
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| Signed-off | October 15, 1999[102KB] | January 1, 2003 |
| Rev. 1 | June 26, 2014[24.8KB] | April 1, 2016 |
Suppressed items
Following six items were suppressed from the PDG work programme in September, 2017.
(Please also see the PDG September 2017 Rockville Meeting Highlights[60.5KB].)
| Harmonization Item | Sign-off | Implementation |
|---|---|---|
| G-08 / Inhalation | - | - |
| G-12 / Porosimetry by Mercury Intrusion | May 8, 2007[89.7KB] | - |
| G-17 / Uniformity of Delivered Dose of Inhalations | - | - |
| G-18 / Microcalorimetry | June 15, 2011[44.0KB] | - |
| G-19 / Density of Solids | - | - |
| B-04 / Protein Determination <G3-12-172> Total Protein Assay |
September 10, 2002[93.0KB] | - |