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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.

 

EP HARMONISATION STATUS  FOR GENERAL TEXTS (as of 30 October 2019)

PDG#

Ph. Eur. general texts name (Ph. Eur. number)

Coordinating pharmacopoeia

Elaboration/Revision/Correction

Sign-off document

On-going 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 on-going (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 on-going (Stage 2)

B-06

Electrophoresis (2.2.31)

Ph. Eur.

Revision 1

B06_1999_09_Sign-off

_

G-01

Particle-size distribution estimation by analytical sieving (2.9.38)

USP

Revision 1

G01_Rev1_2007_05_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 on-going (Stage 2)

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 on-going (Stage 2)

G-06

Friability of uncoated tablets (2.9.7)

USP

Elaboration

G06_2004_02_Sign-off

_

G-07

Elemental impurities (5.20)

USP

Elaboration

_

Elaboration on-going (Stage 2)

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

_

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 on-going (Stage 1)

G-14

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

Ph. Eur.

Elaboration

G14_2008_11_Sign-off

Revision 1 on-going (Stage 2)

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)

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

_

Elaboration on-going (Stage 2)

G-21

Particle size analysis by dynamic light scattering (2.9.50)

JP

Elaboration

_

Elaboration on-going (Stage 1)

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

_

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

Q5a_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

Q5c_2005_11_08_Sign-off

_

Revision of the sign-off cover sheet

Q5c_Rev1_2013_06_Sign-off

_

Revision of the sign-off cover sheet

Q5c_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

_

Q-09

Particulation contamination: sub-visible particles (2.9.19)

Ph. Eur.

Revision 1

2004 06 10 Q09 Rev1 sign-off

Revision 2 on-going (Stage 1)

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: coordinating 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)

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