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

PDG (Pharmacopoeial Discussion Group) Signed-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 signed-off cover sheets but full texts of the harmonized documents are published. (Please also see the PDG November 2020 Videoconference Meeting Highlights.)

As of August 11, 2021
Harmonization Item JP General Test
/General Information
Sign-off Implementation
Q-01 / Dissolution
Signed-off
Rev. 1
Rev. 2
Rev. 3
Rev. 3, Corr. Sign-off cover sheet
Rev. 3, Corr. Sign-off cover sheet
<6.10> Dissolution Test
June 22, 2004
Nov. 8, 2005
Nov. 12, 2008
June 10, 2010
Oct. 3, 2018
Oct. 2, 2019

Apr. 1, 2006
-
July 30, 2010
Oct. 1, 2010
-
-
Q-02 / Disintegration
Signed-off
Rev. 1
Rev. 1, Corr.1
<6.09> Disintegration Test
June 21, 2004
Oct. 30, 2007
Oct. 3, 2018

Apr. 1, 2006
Mar. 31, 2009
-
Q-03/04 / Uniformity of Content/Mass
Signed-off
Rev. 1
Rev. 1, Revised Sign-off cover sheet
Rev. 1, Rev. of Sign-off cover sheet
Rev. 2
Rev. 2, Corr. 1
<6.02> Uniformity of Dosage Units

Feb. 18, 2004
Nov. 9, 2010
June 15, 2011

Nov. 6, 2013

Nov. 4, 2015
Oct. 26, 2016


Apr. 1, 2006
May 31, 2013
-

-

Dec. 1, 2017
-
Q-05a / Tests for Specified Microorganism
Signed-off
Rev. 1
<4.05> Microbiological Examination
of Non-sterile Products


Nov. 8, 2005
June 5, 2008


Oct. 1, 2007
Mar. 31, 2009
Q-05b / Microbial Enumeration
Signed-off
Rev. 1
Rev. 1, Corr. 1
<4.05> Microbiological Examination
of Non-sterile Products

Nov. 8, 2005
June 5, 2008
June 10, 2009

Oct. 1, 2007
Mar. 31, 2009
Apr. 1, 2011
Q-05c / Limits for Non-sterile Products
Signed-off
Rev. of Sign-off cover sheet
Corr. of Sign-off cover sheet
<G4-1-170> Microbial Attributes of Non-sterile
Pharmaceutical Products


Nov. 8, 2005
June 27, 2013
Oct. 3, 2018


Oct. 1, 2007
-
-
Q-06 / Bacterial Endotoxins
Signed-off
Rev. 1
Rev. 1, Corr. 1
Rev. 2
<4.01> Bacterial Endotoxins Test
Jan. 3, 2000
Nov. 11, 2008
Oct. 27, 2009
June 15, 2011

Apr. 1, 2001
Apr. 1, 2011
Apr. 1, 2011
Oct. 1, 2012
Q-07 / Color (instrumental method)
Signed-off
Rev. 1
(JP draft under development)
Oct. 26, 2016
June 24, 2019


-
(Dec., 2022)
Q-08 / Extractable Volume
Signed-off
Rev. 1
Update to Rev. 1, Sign-off cover sheet
<6.05> Test for Extractable Volume
of Parenteral Preparations

July 18, 2000
June 10, 2004
Nov. 9, 2010

-
July 21, 2005
-
Q-09 / Particulate Contamination
Signed-off
Rev. 1
Rev. 1, Sign-off cover sheet
Update to Rev. 1, Sign-off cover sheet
<6.07> Insoluble Particulate Matter
Test for Injections

May 21, 2001
June 10, 2004
Nov. 9, 2010
June 6, 2012

-
Apr. 1, 2006
Apr. 1, 2011
-
Q-10 / Residue on Ignition
Signed-off
Rev. 1
Rev. 2
<2.44> Residue on Ignition Test
Feb. 11, 2000
Sep. 10, 2002
Aug. 4, 2005

Jan. 1, 2003
Jan. 1, 2005
Apr. 1, 2006
Q-11 / Sterility Test
Signed-off
Rev. 1
Rev. 1, Corr. 1
Rev. 1, Corr. 2
Rev. 1, Corr. 3
<4.06> Sterility Test
Sep. 10, 2002
Oct. 30, 2007
June 3, 2008
Nov. 11, 2008
June 10, 2009

Jan. 1, 2005
Mar. 31, 2009
Mar. 31, 2009
-
Apr. 1, 2011
G-01 / Analytical Sieving
Signed-off
Rev. 1
<3.04> Particle Size Determination
June 10, 2004
May 8, 2007

Apr. 1, 2006
Oct. 1, 2009
G-02 / Bulk Density and Tapped Density
Signed-off
Rev. 1
Rev. 1, Corr. 1
Rev. 2
Rev. 3
<3.01>  Determination of Bulk and
Tapped Densities


May 8, 2007
June 5, 2008
June 10, 2009
June 15, 2011
Nov. 6, 2013


Oct. 1, 2009
Oct. 1, 2009
Apr. 1, 2011
Oct. 1, 2012
Oct. 1, 2012
G-03 / Conductivity
Signed-off
Corr. 1
<2.51> Conductivity Measurement
Sep. 13, 2017
Oct. 2, 2019

June 28, 2019
June 7, 2021
G-04 / Gas Pycnometric Density of Solids
Signed-off
<3.03> Powder Particle Density
Determination


May 8, 2007


Oct. 1, 2009
G-05 / Powder Flow
Signed-off
<G2-3-171> Powder Flow
June 10, 2004

Apr. 1, 2006
G-06 / Tablet Friability
Signed-off
<G6-5-150> Tablet Friability Test
Feb. 18, 2004

Apr. 1, 2006
G-07 / Elemental Impurities (Harmonization work in progress)    
G-09 / Optical Microscopy
Signed-off
<3.04>Particle Size Determination
June 10, 2004

Apr. 1, 2006
G-10 / Powder Fineness
Signed-off
<G2-2-171> Powder Fineness
May 8, 2007

Oct. 1, 2009
G-11 / Specific Surface Area
Signed-off
<3.02> Specific Surface Area by Gas Adsorption
Nov. 10, 2003

Apr. 1, 2006
G-13 / Laser Diffraction Measurement of Particle size
Signed-off
<3.06> Laser Diffraction Measurement of Particle Size

Nov. 11, 2008


Dec. 1, 2017
G-14 / X-Ray Powder Diffraction
Signed-off
Rev. 1
<2.58> X-Ray Powder Diffraction
Method

Oct. 30, 2007
Dec. 22, 2020

Apr. 1, 2011
(Dec., 2022)
G-15 / Water-solid Interaction
Signed-off
<3.05> Water-Solid Interactions:
Determination of Sorption- Desorption Isotherms and of
Water Activity

Oct. 1, 2012
G-16 / Thermal Analysis
Signed-off
<2.52> Thermal Analysis
June 26, 2014

Apr. 1, 2016
G-20 / Chromatography (Harmonization work in progress)    
G-21 / Dynamic Light Scattering (Harmonization work in progress)    
B-01 / Amino Acid Determination
Signed-off
Rev. 1
<G3-2-171> Amino Acid Analysis
Sep. 9, 2002
Oct. 26, 2016

Jan. 1, 2005
Dec. 1, 2017
B-02 / Capillary Electrophoresis
Signed-off
Corr. 1
Corr. 2
Corr. 3
<G3-7-180> Capillary Electrophoresis
Sep. 10, 2002
Oct. 27, 2009
June 9, 2010
Nov. 20, 2018

Jan. 1, 2005
-
July 20, 2010
June 7, 2021
B-03 / Isoelectric Focusing
Signed-off
<G3-6-142> Isoelectric Focusing
Sep. 9, 2002

Jan. 1, 2005
B-05 / Peptide Mapping
Signed-off
Rev. 1
<G3-3-142> Peptide Mapping
Sep. 10, 2002

Jan. 1, 2005
B-06 / Polyacrylamide Gel Electrophoresis
Signed-off
Rev. 1
<G3-8-170> SDS-Polyacrylamide Gel
Electrophoresis


Oct. 15, 1999
June 26, 2014


Jan. 1, 2003
Apr.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 Sep. 10, 2002 -

 

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