Pharmacopoeial Discussion Group

The Committee noted and endorsed the continued participation of WHO as an observer in the work of the Pharmacopoeial Discussion Group (PDG). 

---

Exchanges between pharmacopoeias are co-ordinated by the Pharmacopoeial Discussion Group (PDG) (International Harmonisation 1995) and it is frequent that one pharmacopoeia participates in a collaborative study organized by another pharmacopoeia, or that several pharmacopoeias share the same batch of reference substance to be used in their respective monographs nevertheless, in this case the reference substance can not be considered as harmonized. A new batch of erythromycin was shared between the United States Pharmacopoeia and the European Pharmacopoeia and was established in a common coEaborative study both for the microbiological assay (used in the USP for formulations) and the liquid chromatographic assay (used in the Ph. Eur. and USP for bulk material). 

International Flarmonisation (1995) Harmonisation policies of the Pharmacopoeial discussion group (July 1995). Pharmeuropa 7 4r3-42o. 

Progress on the comparison of monographs for excipients published in The International Pharmacopoeia and those adopted in the Pharmacopoeial Discussion Group (PDG) process was noted. The Committee was pleased to note the offer of technical assistance by the International Pharmaceutical Excipients Council (IPEC). 

Methods of Analysis and Excipient Monographs, in 1989 the Ph Eur. the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP) formed a Pharmacopoeial Discussion Group (PDG) (for details of the PDG process see Table 16.3). However, progress is slow. At the time of... 

REGISTRATION OF HUMAN PHARMACEUTICALS Table 16.3 The pharmacopoeial discussion group process... 

The full utility of this Guideline is dependent on the successful completion of harmonization of pharmacopoeial procedures for several attributes commonly considered in the specification for new drug substances or new drug products. The Pharmacopoeial Discussion Group of the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia has expressed a commitment to achieving harmonization of the procedures in a timely fashion. 

CE is now recognized as a mature technique alongside HPLC and other modern analytical techniques. A harmonized general monograph that presents both theoretical and practical considerations of the technique has been recently adopted by the Pharmacopoeial Discussion Group (PDG) for implementation into the USP, the... 

---