Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters)

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 24, 2025

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. of Sign-off cover sheet	October 3, 2018[452KB]	-
Rev. 3, Corr. of 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	June 24, 2025[779KB]	(Fall 2027)

• 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	May 2, 2025[529KB]	(April, 2026)

• 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. 1, Corr. 1, Sign-off cover sheet ver. 2	December 6, 2024[493KB]	-
Rev. 2	(Stage 1)

• G-02 / Bulk Density of Powders <3.01> Determination of Bulk Density

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 <G2-3-182> 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 3A)

• 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	(Stage 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
Rev. 1, Corr. 1	December 6, 2024[584KB]	(April , 2026)

• 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 <G3-3-182> 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]	-