The following table provides useful information about all the general texts on the Pharmacopoeial Discussion Group (PDG) work plan. It also includes the sign-off coversheets and, as of December 2020, the full PDG sign-off texts. The coversheets provide detailed helpful information about harmonised parts and local requirements for all individual texts having undergone harmonisation by the PDG. Information is updated after each PDG meeting.

 

PH. EUR. HARMONISATION STATUS FOR GENERAL TEXTS (as of 1 August 2024)

PDG general texts
name (PDG#)

Ph. Eur. general texts

name (Ph. Eur. number)

Co-ordinating pharmacopoeia

Latest harmonised version

Sign-off document

Ongoing work

Amino Acid Determination (B-01)

Amino acid analysis (2.2.56)

USP

Revision 1

B01_Rev1_2016_10_Sign-off

_

Capillary Electrophoresis (B-02)*

Capillary electrophoresis (2.2.47)

Ph. Eur.

Correction 3 

B02_Corr3_2018_12_Sign-off

Revision 1 ongoing (Stage 2)

Isoelectric Focusing (B-03)

Isoelectric focusing (2.2.54)

Ph. Eur.

Elaboration

B03_2002_09_Sign-off

_

Protein Determination (B-04)

Total protein (2.5.33)

USP

_

_

Suppressed from the PDG work programme in Sept. 2017

Peptide Mapping (B-05)

Peptide mapping (2.2.55)

USP

Revision 1

B-05_Rev1_2023_01_
Sign-off

_

Polyacrylamide Gel Electrophoresis (B-06)*

Electrophoresis (2.2.31)

Ph. Eur.

Revision 1

B06
_Rev1_2014_06_
sign-off

_

Analytical Sieving (G-01)*

Particle-size distribution estimation by analytical sieving (2.9.38)

USP

Revision 1 Correction 1

G01_2021_10_Rev1_Corr1_
Sign-off

Revision 2 ongoing (Stage 1)

Bulk Density of powders (G-02)*

Bulk density of powders (2.9.34)

Ph. Eur.

Revision 4 Correction 2

G02_Rev4_Corr2_2024_06_Sign-off

-

Conductivity (G-03)

Conductivity (2.2.38)

USP

Correction 1

G03_2019-10_Corr1_
Sign-off

_

Gas Pycnometric Density of Solids (G-04)

Gas pycnometric density of solids (2.9.23)

Ph. Eur.

Elaboration

G04_2007_05_
Sign-off

_

Powder Flow (G-05)

Powder flow (2.9.36)

USP

Revision 1

G-05_Rev1_2023_01_Sign-off

-

Tablet Friability (G-06)*

Friability of uncoated tablets (2.9.7)

USP

Sign-off cover sheet version 2 Revision 1

G06-2024_06_Rev1_cover_sheet_ver2_sign-off

-

Elemental Impurities (G-07)

Determination of elemental impurities (2.4.20)

USP

Elaboration

G07_2024_06_Sign-off

-

Inhalation (G-08)

Preparations for inhalation: aerodynamic assessment of fine particles (2.9.18)

Ph. Eur.

-

_

Suppressed from the PDG work programme in Sept. 2017

Optical Microscopy (G-09)

Optical microscopy (2.9.37)

USP

Elaboration

G09_2004_06_Sign-off

Revision 1 ongoing (Stage 1)

Powder Fineness (G-10)

Powder fineness (2.9.35)

USP

Elaboration

G10_2007_05_Sign-off

_

Specific Surface Area (G-11)

Specific surface area by gas adsorption (2.9.26)

Ph. Eur.

Elaboration

G11_2003_11_Sign-off

_

Porosimetry by Mercury Intrusion (G-12)

Porosity and pore-size distribution of solids by mercury porosimetry (2.9.32)

Ph. Eur.

-

_

Suppressed from the PDG work programme in Sept. 2017

Laser Diffraction Measurement of Particle size (G-13)

Particle size analysis by laser light diffraction (2.9.31)

Ph. Eur.

Elaboration

G13_2008_11_
Sign-off

Revision 1 ongoing (Stage 2)

X-Ray Powder Diffraction (G-14)

Characterisation of crystalline and partially crystalline solids by X-ray powder diffraction (XRPD) (2.9.33)

Ph. Eur.

Revision 1

G14_Rev1_2020_12_
Sign-off

_

Water-solid Interaction (G-15)

Water-solid Interactions: determination of sorption-desorption isotherms and of water activity (2.9.39)

Ph. Eur.

Elaboration

G15_2009_10_
Sign-off

_

Thermal Analysis (G-16)

Thermal analysis (2.2.34)

Ph. Eur.

Elaboration

G16_2014_06_
Sign-off

Revision 1 ongoing (Stage 1)

Uniformity of Delivered Dose of Inhalations (G-17)

Preparations for inhalation (0671) - Uniformity of Delivered Dose of Inhalations

Ph. Eur.

_

_

Suppressed from the PDG work programme in Sept. 2017

Microcalorimetry (G-18)

Characterisation of crystalline solids by microcalorimetry and solution calorimetry (2.2.61)

Ph. Eur.

-

_

Suppressed from the PDG work programme in Sept. 2017

Density of solids (G-19)

Density of solids (2.2.42)

Ph. Eur.

_

_

Suppressed from the PDG work programme in Sept. 2017

Chromatography (G-20)

Chromatographic separation techniques (2.2.46)

Ph. Eur.

Correction 1

G20_Corr1_2023_10_Sign-off

 

Dynamic Light Scattering (G-21)

Particle size analysis by dynamic light scattering (2.9.50)

JP

Correction 1

G-21_Corr1_2023_06_Sign-off

-

Dissolution (Q-01)*

Dissolution test for solid dosage forms (2.9.3)

USP

Correction of the sign-off cover sheet

Q01_2019-10_
Corr_cover_
sheet_ Sign-off

Revision 5 ongoing (Stage 2)

Disintegration (Q-02)*

Disintegration of tablets and capsules (2.9.1)

USP

Revision 1 Correction 1

Q02 Rev1
Corr1 2018 10 03
Sign-off

Revision 2 ongoing (Stage 3)

Uniformity of Content/Mass (Q03/04)*

Uniformity of dosage units (2.9.40)

USP

Revision 2 Correction 1

Q03 Rev2
Corr1 2016 10 26
Sign-off

Tests for Specified Microorganism (Q-05a)*

Microbial examination of non-sterile products: test for specified micro-organisms (2.6.13)

Ph. Eur.

Revision 1

Q05a_
Rev1_2008_06_
Sign_off

_

Microbial Enumeration (Q-05b)*

Microbial enumeration of non-sterile products: microbial enumeration tests (2.6.12)

Ph. Eur.

Revision 1 Correction 2

Q05b_Rev1_Corr2_2023_07_Sign-off

_

Limits for Non-sterile Products
(Q-05c)*

Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use (5.1.4)

Ph. Eur.

Elaboration

Q05c_2005_11_08_
Sign-off

_

Correction of the sign-off cover sheet

Q05c_Rev1_Corr_cover_sheet_2013_06_ Sign-off

_

Correction 2 of the sign-off cover sheet

Q05c_
Corr2_cover_sheet_2018_
10_
Sign-off

_

Bacterial Endotoxins
(Q-06)*

Bacterial endotoxins (2.6.14)

JP

Revision 2

Q06_Rev2_2011_06_
Sign-off

_

Color (instrumental
method) (Q-07)

Degree of coloration of liquids (2.2.2)

Ph. Eur.

Revision 1

Q07_Rev1_2019-06_
Sign off

_

Extractable Volume
(Q-08)*

Test for extractable volume of parenteral preparations (2.9.17)

Ph. Eur.

Correction of the sign-off cover sheet Revision 1

Q08_Rev1_Corr_cover_sheet_2010_11_
Sign-off

Revision 2 ongoing (Stage 2)

Particulate
Contamination (Q-09)*

Particulation contamination: sub-visible particles (2.9.19)

Ph. Eur.

Revision 1

Q09_Rev1_2004_06_
Sign-off

Revision 2 ongoing (Stage 3)

Residue on Ignition (Q-10)*

Sulfated ash (2.4.14)

JP

Revision 2

Q10_Rev2_2005_08_
Sign-off

_

Sterility Test (Q-11)*

Sterility (2.6.1)

Ph. Eur.

Revision 1 Correction 3

Q11_Rev1_
Corr3_2009_06_
Sign-off

_

 

* This harmonised pharmacopoeial text is declared interchangeable via an annex to the ICH Q4B guideline.  Where such status is indicated, any of the official texts from JP, Ph. Eur., USP or from the other pharmacopoeias referenced in the Q4B Annex can be substituted one for the other (appropriately referenced) in the ICH countries/regions for purposes of the pharmaceutical registration/approval process. Using any of the interchangeable methods, an analyst will reach the same accept or reject decisions irrespective of which pharmacopoeia referenced in the Q4B Annex is used. More information is available on the ICH website

Abbreviations

CP: co-ordinating pharmacopoeia

JP: Japanese Pharmacopoeia

Ph. Eur.: European Pharmacopoeia

USP: United States Pharmacopeia

 

Old procedure (until March 30, 2018)

Current procedure

Stage 1: Identification

Stage 1: Preparation of first draft

Stage 2: Investigation

Stage 3: Proposal for Expert Committee Review

Stage 4: Official Inquiry

Stage 2: Official Inquiry

Stage 5: Consensus

Stage 3: Consensus

Stage 6: Regional Adoption and Implementation

Stage 4: Regional Adoption and Implementation

Stage 7: Inter-Regional Acceptance

Stage 5: Inter-Regional Acceptance (for texts previously evaluated by ICH Q4B for regulatory Interchangeability)