Submitting a Monograph
Technical Information Requirements For Monograph Review
Approved April 2014
The following guidelines are presented to help monograph sponsors for homeopathic medicines assemble and present Chemistry, Manufacturing and Controls (CMC) and Safety information in a manner and format consistent with the expectations of the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) Monograph Review Committee (MRC) for approval; and to help guide reviewers who examine monograph submissions to ensure that expected standards of quality are being upheld. These guidelines contain two specific types of criteria: requirements and best practice recommendations. Requirements are recognized by language that is definitive, such as “should” [shall] or “will include”, while best practice recommendations will use qualifiers such as “is recommended”. For monograph approval, the submitted CMC and Safety information must meet all requirements.
Monograph reviewers are instructed to ensure the following criteria are met:
- The definition, description, nomenclature and general properties of the raw material offered for inclusion within the Homeopathic Pharmacopoeia of the United States (HPUS) are adequately described (Section 3).
- The Manufacturing locations, processes and control of materials are identified where appropriate (Section 4).
- The structure elucidation and characterization of the raw material, active principles of complex drug substances and their impurities, are, where appropriate, defined (Section 5).
- The quality, storage conditions and stability of the raw material, are, where needed, clearly stated.
- The safety of the starting material is established on a basis that allows for appropriate calculation of OTC, Rx and, where appropriate, external attenuations levels.
- Requirements A requirement that must be met for approval of the monograph. Non-compliance with these requirements will likely cause non-approval of a monograph. Requirements will be periodically updated as needed. Requirements contained within these guidelines for monograph submission are recognizable by language that implies a required element, placement in the left column of the document, and appearance in the text as regular font.
- Best Practice Recommendation: Suggested method or practices or particular point that should be considered when conducting development and documentation of the raw material. Best practices will be updated as standards evolve. Best practice recommendations contained within these guidelines for monograph submission are recognizable by language describing the element as “recommended”, placement in the right column of the document, and appearance in the text as italicized font.