Harmonisation status for General Texts (PDG)
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.
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PH. EUR. HARMONISATION STATUS FOR GENERAL TEXTS (as of 1 August 2024) |
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PDG general texts |
Ph. Eur. general texts name (Ph. Eur. number) |
Co-ordinating pharmacopoeia |
Latest harmonised version |
Sign-off document |
Ongoing work |
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Amino Acid Determination (B-01) |
Amino acid analysis (2.2.56) |
USP |
Revision 1 |
_ |
|
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Capillary Electrophoresis (B-02)* |
Capillary electrophoresis (2.2.47) |
Ph. Eur. |
Correction 3 |
Revision 1 ongoing (Stage 2) |
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| Isoelectric Focusing (B-03) |
Isoelectric focusing (2.2.54) |
Ph. Eur. |
Elaboration |
_ |
|
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Protein Determination (B-04) |
Total protein (2.5.33) |
USP |
_ |
_ |
Suppressed from the PDG work programme in Sept. 2017 |
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Peptide Mapping (B-05) |
Peptide mapping (2.2.55) |
USP |
Revision 1 |
_ |
|
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Polyacrylamide Gel Electrophoresis (B-06)* |
Electrophoresis (2.2.31) |
Ph. Eur. |
Revision 1 |
_ |
|
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Analytical Sieving (G-01)* |
Particle-size distribution estimation by analytical sieving (2.9.38) |
USP |
Revision 1 Correction 1 |
Revision 2 ongoing (Stage 1) |
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Bulk Density of powders (G-02)* |
Bulk density of powders (2.9.34) |
Ph. Eur. |
Revision 4 Correction 2 |
- |
|
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Conductivity (G-03) |
Conductivity (2.2.38) |
USP |
Correction 1 |
_ |
|
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Gas Pycnometric Density of Solids (G-04) |
Gas pycnometric density of solids (2.9.23) |
Ph. Eur. |
Elaboration |
_ |
|
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Powder Flow (G-05) |
Powder flow (2.9.36) |
USP |
Revision 1 |
- |
|
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Tablet Friability (G-06)* |
Friability of uncoated tablets (2.9.7) |
USP |
Sign-off cover sheet version 2 Revision 1 |
- |
|
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Elemental Impurities (G-07) |
Determination of elemental impurities (2.4.20) |
USP |
Elaboration |
- |
|
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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 |
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Optical Microscopy (G-09) |
Optical microscopy (2.9.37) |
USP |
Elaboration |
Revision 1 ongoing (Stage 1) |
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Powder Fineness (G-10) |
Powder fineness (2.9.35) |
USP |
Elaboration |
_ |
|
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Specific Surface Area (G-11) |
Specific surface area by gas adsorption (2.9.26) |
Ph. Eur. |
Elaboration |
_ |
|
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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 |
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Laser Diffraction Measurement of Particle size (G-13) |
Particle size analysis by laser light diffraction (2.9.31) |
Ph. Eur. |
Elaboration |
Revision 1 ongoing (Stage 2) |
|
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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 |
_ | |
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Water-solid Interaction (G-15) |
Water-solid Interactions: determination of sorption-desorption isotherms and of water activity (2.9.39) |
Ph. Eur. |
Elaboration |
_ |
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Thermal Analysis (G-16) |
Thermal analysis (2.2.34) |
Ph. Eur. |
Elaboration |
Revision 1 ongoing (Stage 1) |
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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 |
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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 |
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Density of solids (G-19) |
Density of solids (2.2.42) |
Ph. Eur. |
_ |
_ |
Suppressed from the PDG work programme in Sept. 2017 |
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Chromatography (G-20) |
Chromatographic separation techniques (2.2.46) |
Ph. Eur. |
Correction 1 |
|
|
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Dynamic Light Scattering (G-21) |
Particle size analysis by dynamic light scattering (2.9.50) |
JP |
Correction 1 |
- |
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Dissolution (Q-01)* |
Dissolution test for solid dosage forms (2.9.3) |
USP |
Correction of the sign-off cover sheet |
Revision 5 ongoing (Stage 2) |
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Disintegration (Q-02)* |
Disintegration of tablets and capsules (2.9.1) |
USP |
Revision 1 Correction 1 |
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Revision 2 ongoing (Stage 3) |
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Uniformity of Content/Mass (Q03/04)* |
Uniformity of dosage units (2.9.40) |
USP |
Revision 2 Correction 1 |
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Tests for Specified Microorganism (Q-05a)* |
Microbial examination of non-sterile products: test for specified micro-organisms (2.6.13) |
Ph. Eur. |
Revision 1 |
_ |
|
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Microbial Enumeration (Q-05b)* |
Microbial enumeration of non-sterile products: microbial enumeration tests (2.6.12) |
Ph. Eur. |
Revision 1 Correction 2 |
_ |
|
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Limits for Non-sterile Products |
Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use (5.1.4) |
Ph. Eur. |
Elaboration |
_ |
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Correction of the sign-off cover sheet |
_ |
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Correction 2 of the sign-off cover sheet |
_ |
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Bacterial Endotoxins |
Bacterial endotoxins (2.6.14) |
JP |
Revision 2 |
_ |
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Color (instrumental |
Degree of coloration of liquids (2.2.2) |
Ph. Eur. |
Revision 1 |
_ |
|
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Extractable Volume |
Test for extractable volume of parenteral preparations (2.9.17) |
Ph. Eur. |
Correction of the sign-off cover sheet Revision 1 |
Revision 2 ongoing (Stage 2) |
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Particulate |
Particulation contamination: sub-visible particles (2.9.19) |
Ph. Eur. |
Revision 1 |
Revision 2 ongoing (Stage 3) |
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Residue on Ignition (Q-10)* |
Sulfated ash (2.4.14) |
JP |
Revision 2 |
_ |
|
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Sterility Test (Q-11)* |
Sterility (2.6.1) |
Ph. Eur. |
Revision 1 Correction 3 |
_ |
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* 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
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Old procedure (until March 30, 2018) |
Current procedure |
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Stage 1: Identification |
Stage 1: Preparation of first draft |
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Stage 2: Investigation |
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Stage 3: Proposal for Expert Committee Review |
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Stage 4: Official Inquiry |
Stage 2: Official Inquiry |
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Stage 5: Consensus |
Stage 3: Consensus |
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Stage 6: Regional Adoption and Implementation |
Stage 4: Regional Adoption and Implementation |
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Stage 7: Inter-Regional Acceptance |
Stage 5: Inter-Regional Acceptance (for texts previously evaluated by ICH Q4B for regulatory Interchangeability) |