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

B01_Rev1_2016_10_Sign-off

_

B-02

Capillary electrophoresis (2.2.47)

Ph. Eur.

Correction 3 

B02_Corr3_2018_12_Sign-off

Revision 1 ongoing (Stage 1)

B-03

Isoelectric focusing (2.2.54)

Ph. Eur.

Elaboration

B03_2002_09_Sign-off

_

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

B05_2002_09_Sign-off

Revision 1 ongoing (Stage 2)

B-06

Electrophoresis (2.2.31)

Ph. Eur.

Revision 1

B06
_Rev1_2014_06_
sign-off

_

G-01

Particle-size distribution estimation by analytical sieving (2.9.38)

USP

Revision 1 Correction 1

G01_2021_10_Rev1_Corr1_
Sign-off

_

G-02

Bulk density and tapped density of powders (2.9.34)

Ph. Eur.

Revision 3

G02_Rev3_2013_11_
Sign_off

Revision 4 ongoing (Stage 3)

G-03

Conductivity (2.2.38)

USP

Correction 1

G03_2019-10_Corr1_
Sign-off

_

G-04

Gas pycnometric density of solids (2.9.23)

Ph. Eur.

Elaboration

G04_2007_05_
Sign-off

_

G-05

Powder flow (2.9.36)

USP

Elaboration

G05_2004_06_Sign-off

Revision 1 ongoing (Stage 3)

G-06

Friability of uncoated tablets (2.9.7)

USP

Revision 1

G06_2022_05_Rev1_Sign-off

_

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

G09_2004_06_Sign-off

Revision 1 ongoing (Stage 1)

G-10

Powder fineness (2.9.35)

USP

Elaboration

G10_2007_05_Sign-off

_

G-11

Specific surface area by gas adsorption (2.9.26)

Ph. Eur.

Elaboration

G11_2003_11_Sign-off

_

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

G13_2008_11_
Sign-off

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

G14_Rev1_2020_12_
Sign-off

_

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

_

G-16

Thermal analysis (2.2.34)

Ph. Eur.

Elaboration

G16_2014_06_
Sign-off

_

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

G20_2021_09_Sign-off

 

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

Q01_2019-10_Corr_
Sign-off

_

Q-02

Disintegration of tablets and capsules (2.9.1)

USP

Revision 1 

Q02 Rev1 2007-10-30
Sign_off

Revision 1 Correction 1

Q02 Rev1
Corr1 2018 10 03
Sign-off

Revision 2 ongoing (Stage 1)

Q03/04

Uniformity of dosage units (2.9.40)

USP

Revision 2 Correction 1

Q03 Rev2
Corr1 2016 10 26
Sign-off

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

_

Q-05b

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

Ph. Eur.

Revision 1 Correction 1

Q05b
rev1_corr1_
2009 06 10
Sign_off

_

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

_

Revision of the sign-off cover sheet

Q05c_Rev1_2013_06_
Sign-off

_

Revision of the sign-off cover sheet

Q05c_2018_10_
Sign-off

_

Q-06

Bacterial endotoxins (2.6.14)

JP

Revision 2

Q06_Rev2_2011_06_
Sign-off

_

Q-07

Degree of coloration of liquids (2.2.2)

Ph. Eur.

Revision 1

Q07_Rev1_2019-06_
Sign off

_

Q-08

Test for extractable volume of parenteral preparations (2.9.17)

Ph. Eur.

Revision of the sign-off cover sheet

Q08_Rev1_2010_11_
Sign-off

Revision 2 ongoing (Stage 1)

Q-09

Particulation contamination: sub-visible particles (2.9.19)

Ph. Eur.

Revision 1

Q09_Rev1_2004_06_
Sign-off

Revision 2 ongoing (Stage 2)

Q-10

Sulfated ash (2.4.14)

JP

Revision 2

Q10_Rev2_2005_08_
Sign-off

_

Q-11

Sterility (2.6.1)

Ph. Eur.

Revision 1 Correction 3

Q11_Rev1_
Corr3_2009_06_
Sign-off

_

 

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)