PDG (Pharmacopoeial Discussion Group) Signed-off Cover Sheets (which provide information such as on harmonized attributes, non-harmonized attributes, and local requirements as well as the signatures of three pharmacopoeias) on the harmonized general chapters are listed.
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 |
(General Information) 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 |
|
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 (Spring, 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 |
(General Information) Powder Flow | June 10, 2004 |
Apr. 1, 2006 |
G-06 / Tablet Friability Signed-off |
(General Information) 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 |
(General Information) 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 |
<2.58> X-Ray Powder Diffraction Method |
Oct. 30, 2007 |
Apr. 1, 2011 |
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 |
(General Information) 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 |
(General Information) Capillary Electrophoresis | Sep. 10, 2002 Oct. 27, 2009 June 9, 2010 Nov. 20, 2018 |
Jan. 1, 2005 - July 20, 2010 (Spring, 2021) |
B-03 / Isoelectric Focusing Signed-off |
(General Information) Isoelectric Focusing | Sep. 9, 2002 |
Jan. 1, 2005 |
B-05 / Peptide Mapping Signed-off Rev. 1 |
(General Information) Peptide Mapping | Sep. 10, 2002 |
Jan. 1, 2005 |
B-06 / Polyacrylamide Gel Electrophoresis Signed-off Rev. 1 |
(General Information)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 | (General Information) Total Protein Assay | Sep. 10, 2002 | - |