Harmonisation status for General Texts (PDG)
The following table summarises the sign-off coversheets for all general texts under the Pharmacopoeial Discussion Group (PDG) work plan. These 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 31 January 2022) |
|||||
|
PDG# |
Ph. Eur. general texts name (Ph. Eur. number) |
Co-ordinating pharmacopoeia |
Elaboration/Revision/Correction |
Sign-off document |
Ongoing work |
|
B-01 |
Amino acid analysis (2.2.56) |
USP |
Revision 1 |
_ |
|
|
B-02 |
Capillary electrophoresis (2.2.47) |
Ph. Eur. |
Correction 3 |
Revision 1 ongoing (Stage 1) |
|
|
B-03 |
Isoelectric focusing (2.2.54) |
Ph. Eur. |
Elaboration |
_ |
|
|
B-04 |
Total protein (2.5.33) |
USP |
Suppressed from the PDG work programme in Sept. 2017 |
_ |
_ |
|
B-05 |
Peptide mapping (2.2.55) |
USP |
Elaboration |
Revision 1 ongoing (Stage 2) |
|
|
B-06 |
Electrophoresis (2.2.31) |
Ph. Eur. |
Revision 1 |
_ |
|
|
G-01 |
Particle-size distribution estimation by analytical sieving (2.9.38) |
USP |
Revision 1 Correction 1 |
_ |
|
|
G-02 |
Bulk density and tapped density of powders (2.9.34) |
Ph. Eur. |
Revision 3 |
Revision 4 ongoing (Stage 3) |
|
|
G-03 |
Conductivity (2.2.38) |
USP |
Correction 1 |
_ |
|
|
G-04 |
Gas pycnometric density of solids (2.9.23) |
Ph. Eur. |
Elaboration |
_ |
|
|
G-05 |
Powder flow (2.9.36) |
USP |
Elaboration |
Revision 1 ongoing (Stage 3) |
|
|
G-06 |
Friability of uncoated tablets (2.9.7) |
USP |
Elaboration |
Revision 1 ongoing (Stage 3) |
|
|
G-07 |
Elemental impurities (5.20) |
USP |
Elaboration |
_ |
Elaboration ongoing (Stage 3) |
|
G-08 |
Preparations for inhalation: aerodynamic assessment of fine particles (2.9.18) |
Ph. Eur. |
Suppressed from the PDG work programme in Sept. 2017 |
_ |
_ |
|
G-09 |
Optical microscopy (2.9.37) |
USP |
Elaboration |
Revision 1 ongoing (Stage 1) |
|
|
G-10 |
Powder fineness (2.9.35) |
USP |
Elaboration |
_ |
|
|
G-11 |
Specific surface area by gas adsorption (2.9.26) |
Ph. Eur. |
Elaboration |
_ |
|
|
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 |
_ |
_ |
|
G-13 |
Particle size analysis by laser light diffraction (2.9.31) |
Ph. Eur. |
Elaboration |
Revision 1 ongoing (Stage 1) |
|
|
G-14 |
Characterisation of crystalline and partially crystalline solids by X-ray powder diffraction (XRPD) (2.9.33) |
Ph. Eur. |
Revision 1 |
_ | |
|
G-15 |
Water-solid Interactions: determination of sorption-desorption isotherms and of water activity (2.9.39) |
Ph. Eur. |
Elaboration |
_ |
|
|
G-16 |
Thermal analysis (2.2.34) |
Ph. Eur. |
Elaboration |
_ |
|
|
G-17 |
Preparations for inhalation (0671) - Uniformity of Delivered Dose of Inhalations |
Ph. Eur. |
_ |
_ |
Bilateral harmonisation (EP/JP) |
|
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 |
_ |
_ |
|
G-19 |
Density of solids (2.2.42) |
Ph. Eur. |
_ |
_ |
Bilateral harmonisation (EP/USP) |
|
G-20 |
Chromatographic separation techniques (2.2.46) |
Ph. Eur. |
Elaboration |
|
|
|
G-21 |
Particle size analysis by dynamic light scattering (2.9.50) |
JP |
Elaboration |
_ |
Elaboration ongoing (Stage 3) |
|
Q-01 |
Dissolution test for solid dosage forms (2.9.3) |
USP |
Revision of the sign-off cover sheet |
_ |
|
|
Q-02 |
Disintegration of tablets and capsules (2.9.1) |
USP |
Revision 1 |
||
|
Revision 1 Correction 1 |
Revision 2 ongoing (Stage 1) |
||||
|
Q03/04 |
Uniformity of dosage units (2.9.40) |
USP |
Revision 2 Correction 1 |
||
|
Q-05a |
Microbial examination of non-sterile products: test for specified micro-organisms (2.6.13) |
Ph. Eur. |
Revision 1 |
_ |
|
|
Q-05b |
Microbial enumeration of non-sterile products: microbial enumeration tests (2.6.12) |
Ph. Eur. |
Revision 1 Correction 1 |
_ |
|
|
Q-05c |
Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use (5.1.4) |
Ph. Eur. |
Elaboration |
_ |
|
|
Revision of the sign-off cover sheet |
_ |
||||
|
Revision of the sign-off cover sheet |
_ |
||||
|
Q-06 |
Bacterial endotoxins (2.6.14) |
JP |
Revision 2 |
_ |
|
|
Q-07 |
Degree of coloration of liquids (2.2.2) |
Ph. Eur. |
Revision 1 |
_ |
|
|
Q-08 |
Test for extractable volume of parenteral preparations (2.9.17) |
Ph. Eur. |
Revision of the sign-off cover sheet |
Revision 2 ongoing (Stage 1) |
|
|
Q-09 |
Particulation contamination: sub-visible particles (2.9.19) |
Ph. Eur. |
Revision 1 |
Revision 2 ongoing (Stage 2) |
|
|
Q-10 |
Sulfated ash (2.4.14) |
JP |
Revision 2 |
_ |
|
|
Q-11 |
Sterility (2.6.1) |
Ph. Eur. |
Revision 1 Correction 3 |
_ |
|
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) |