Pharmacopeial Discussion Group (PDB) Glossary

  • Harmonized monograph or general chapter: Text that has reached Stage 5B and that has been countersigned by the three PDG pharmacopeias.
  • Full harmonization: A monograph or a general chapter  having the same tests, test procedures, and acceptance criteria in all three PDG pharmacopeias.
  • Harmonization by attribute: A monograph or a general chapter that contains a combination of harmonized and nonharmonized tests or sections.
  • Interchangeability: A test or a section of a monograph or a general chapter, where the accept/reject decision is the same for all three pharmacopeias regardless of which of the tests or sections of the individual PDG pharmacopeia is used.
  • Local attributes: Specific attributes of local or national origin unique to that pharmacopeia in addition to the PDG harmonized/nonharmonized attributes of a particular monograph or general chapter.
  • Nonharmonized attributes: All three pharmacopeias agree that the attribute/provision should be included but have not come to an agreement on the method and/or limit.