Etat des travaux du GDP

© Pharmeuropa | Harmonisation des pharmacopées | Août 2015
1
Etat des travaux du GDP
(Juillet 2015)
Item
Coordinating pharmacopoeia
Stage
General methods relevant to Q6A
Dissolution (rev. 3)
USP
6
Disintegration (rev. 1)
USP
6
Uniformity of content/mass (rev. 1)
USP
6
Tests for specified microorganisms (rev. 1)
Ph. Eur.
6
Microbial enumeration (rev. 1, corr. 1)
Ph. Eur.
6
Microbial contamination limits for non-sterile products
Ph. Eur.
6
Bacterial endotoxins (rev. 2)
JP
6
Color (instrumental method)
Ph. Eur.
4
Extractable volume of parenterals (rev. 1)
Ph. Eur.
6
Test for particulate contamination: subvisible particles (rev. 1)
Ph. Eur.
6
Residue on ignition (rev. 2)
JP
6
Sterility test (rev. 1, corr. 3)
Ph. Eur.
6
USP
6
Ph. Eur.
6
USP
4
Ph. Eur.
6
Flowability (powder flow)
USP
6
Tablet friability
USP
6
Metal impurities
USP
3
Ph. Eur.
4 rev. 3
Optical microscopy
USP
6
Powder fineness
USP
6
Specific surface area
Ph. Eur.
6
Porosimetry by mercury intrusion
Ph. Eur.
6
Laser diffraction measurement of particle size
Ph. Eur.
6
X-ray powder diffraction
Ph. Eur.
6
Water-solid interaction
Ph. Eur.
6
Thermal analysis
Ph. Eur.
6
Uniformity of delivered dose of inhalation
Ph. Eur.
2
Microcalorimetry
Ph. Eur.
6
Density of solids
Ph. Eur.
6
Chromatography
Ph. Eur.
3 rev. 3
JP
2
General chapters
Analytical sieving (rev. 1)
Bulk density and tapped density (rev. 3)
Conductivity
Gas pycnometric density of solids
Inhalation
Dynamic Light Scattering
2
© Pharmeuropa | Harmonisation des pharmacopées | Août 2015
Item
Coordinating pharmacopoeia
Stage
Methods for biotechnology products
Amino acid determination
USP
6
Capillary electrophoresis (corr. 2)
Ph. Eur.
6
Isoelectric focusing
Ph. Eur.
6
Protein determination (rev. 1)
USP
4
Peptide mapping (rev. 1)
USP
4 rev. 1
Ph. Eur.
6
Alcohol (rev. 2, corr 2)
Ph. Eur.
6
Dehydrated alcohol (rev. 2, corr 2)
Ph. Eur.
6
Benzyl alcohol (rev. 2, corr. 1)
Ph. Eur.
6
Butyl paraben (rev. 1)
Ph. Eur.
6
Calcium carbonate (bilateral harmonisation: Ph. Eur./JP)
JP
4
Calcium disodium edetate (rev. 1)
JP
3
Calcium phosphate dibasic (anhydrous) (rev. 2)
JP
2
Calcium phosphate dibasic (rev. 1)
JP
6
Carmellose (rev. 1)
JP
6
Carmellose calcium (rev. 1)
USP
6
Carmellose sodium
USP
3 rev. 2
Cellulose acetate (rev. 2)
USP
6
Cellulose acetate phthalate (rev. 1, corr. 1)
USP
6
Cellulose, powdered (rev. 1)
USP
6
Citric acid, anhydrous (rev. 2)
Ph. Eur.
6
Citric acid, monohydrate (rev. 2)
Ph. Eur.
6
JP
3 rev. 1
USP
6
Crospovidone
Ph. Eur.
6
Ethylcellulose (rev. 2)
Ph. Eur.
4
Ethyl paraben (rev. 1, corr. 1)
Ph. Eur.
6
Gelatin, gelling grade (corr. 2)
Ph. Eur.
6
Gelatin, non-gelling grade (corr. 2)
Ph. Eur.
6
Glucose monohydrate/anhydrous (corr. 1)
Ph. Eur.
6
Glycerin
USP
3
Glyceryl monostearate
USP
3*
Hydroxyethylcellulose
Ph. Eur.
4 rev. 1
Hydroxypropylcellulose
USP
6
Hydroxypropylcellulose, low substituted (corr. 1)
USP
6
JP
6
USP
6
Polyacrylamide gel electrophoresis (rev. 1)
Excipients
Copovidone
Croscarmellose sodium
Hydroxypropylmethylcellulose (Hypromellose) (rev. 1,
corr. 2)
Hypromellose phthalate (rev. 1, corr. 2)
© Pharmeuropa | Harmonisation des pharmacopées | Août 2015
Item
3
Coordinating pharmacopoeia
Stage
Ph. Eur.
6
Lactose, anhydrous (rev. 5)
USP
2
Lactose for inhalation
USP
3
Lactose, monohydrate (rev. 3)
USP
3
Magnesium stearate (corr. 3)
USP
6
Ph. Eur.
6
Methylcellulose (rev. 2, corr. 2)
JP
6
Methyl paraben (rev. 1, corr. 1)
JP
6
Microcrystalline cellulose (rev. 1)
USP
6
Petrolatum
USP
4 rev. 1
Petrolatum, white
USP
4 rev. 1
Polyethylene glycol
USP
4 rev. 3
Ph. Eur.
6
Povidone (rev. 1)
JP
6
Propylene glycol
Ph. Eur.
4
Propyl paraben (rev. 1, corr. 1)
Ph. Eur.
6
Saccharin (rev. 1)
USP
6
Saccharin, calcium (rev. 1)
USP
1*
Saccharin, sodium (rev. 2)
USP
6
Silicon dioxide
JP
4 rev. 2
Silicon dioxide, colloidal
JP
4 rev. 2
Sodium chloride (rev. 3)
Ph. Eur.
6
Sodium laurylsulfate
USP
6
Sodium starch glycolate (rev. 3) rev. 4*
USP
6
Starch, corn (rev. 3)
USP
6
Starch, potato (rev. 2)
Ph. Eur.
6
Starch, pregelatinised
JP
3 rev. 1
Starch, rice (rev. 1)
Ph. Eur.
6
Starch, wheat (rev. 2)
Ph. Eur.
6
Stearic acid (rev. 1, corr. 2)
Ph. Eur.
6
Sucrose
Ph. Eur.
6
Talc (rev. 1)
Ph. Eur.
6
JP
5A3*
USP
4
Isomalt
Mannitol (corr. 1)
Polysorbate 80 (corr. 2)
Titanium dioxide
Water for injection in containers
* Supprimé du programme de travail
Etape 1 : Identification
Etape 2 : Investigation
Etape 3 : Proposition
Etape 4 : Enquête publique officielle
Etape 5A : Consensus provisoire
Etape 5B : Consensus final texte « sign-off »
Etape 6 : Adoption régionale et mise en application
Etape 7 : Acceptation interrégionale