Harmonization retrospective

For a subject to be harmonized retrospectively, the coordinating pharmacopeia collects the information on the existing specifications in the three pharmacopeias, on the grades of products marketed, and on the potential analytical procedures. 

Two additional concepts of harmonization include prospective—to avoid conflicts among pharmacopeial standards before they occur, and retrospective—to resolve conflicts among existing pharmacopeial standards,... 

Articulating the three concepts for harmonization was particularly important. Prospective and retrospective clarify the distinction between work required to avoid conflict when establishing standards for pharmacopeial articles for which standards do not exist, or where few standards exist among the pharmacopeias, from work required to reconcile differences among well-established standards for articles that may have been in the pharmacopeias for considerable time. Prospective harmonization was inaugurated for biotechnology-derived products. Retrospective harmonization focused on pharmaceutical excipients and analytical tests and methods. Forward harmonization expresses a philosophy and environment for harmonization consistent with advances in pharmaceutical analysis. 

Experience gained by harmonizing the first of the excipients. Lactose and Magnesium Stearate showed that because so many parties are affected and many expert groups must be convened, forward, retrospective harmonization is intrinsically a lengthy process. 

Harmonization may be carried out retrospectively for existing monographs or chapters or prospectively for new monographs or chapters. The three pharmacopeias have a commitment to respect the agreed working procedures and the associated time deadlines as an essential part of the harmonization procedure. The PDG has defined harmonization of a pharmacopeial monograph or general chapter as follows ... 

Stromberg L, Lundberg L, Neumann H, Bobon B, Huizer H, and Van der Stelt NW (2000) Heroin impurity profiling. A harmonization study for retrospective comparisons. Forensic Science International 114 67-88. 

Source Stromberg, L., et al. "Heroin Impurity Profiling A Harmonization Study for Retrospective Comparisons." Forensic Science International 114 (2000), 67-88. 

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