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