Pharmacopoeia is a reference book for the preparation of quality medicines published by the authority of a government or a concerned society (e.g., British pharmacopoeia, Indian pharmacopoeia, Japanese pharmacopoeia), while herbal pharmacopoeia and therapeutic compendium represent qualitative and therapeutic monographs on botanicals (description of preparation on single topic). A pharmacopoeial monograph is a compiled data about Active Pharmaceutical Ingredients (API) or Products (APP) with its identification tests, assay method, impurity profile, test for impurity, solubility, etc. An herbal monograph is a document that defines a botanical drug and provides information that allows for its proper identification. It contains the basic description including nomenclature, part used, constituents, range of application, contraindications and side effects, incompatibilities with other medications, dosage, use, and action of the herb. Pharmacopoeia is an essential reference for all individuals and organizations working within pharmaceutical research and development, manufacture and testing around the globe. Herbal pharmacopoeia intends to promote the responsible use of herbal medicines with the highest possible degree of efficacy and safety through the development of standards of identity, purity, and analysis for botanicals including the review of traditional and scientific data regarding their efficacy and safety. The American Herbal Pharmacopoeia (AHP) and those of other nations (e.g., the British pharmacopoeia, the European pharmacopoeia, the pharmacopoeia of the People’s Republic of China, the Indian Ayurvedic pharmacopoeia) intend to promote the responsible use of herbal medicines with the highest possible degree of efficacy and safety and disseminate such information through monographs and other publications. BP is now used in over 100 countries as an essential reference; the American Herbal Pharmacopoeia (AHP) intends to produce 300 monographs on botanicals including many of the Ayurvedic, Chinese, and Western herbs most frequently used in the USA; pharmacopoeia of the People’s Republic of China (PPRC, Eng. ed. 2000) contains monographs for hundreds of medicinal plants used in Traditional Chinese Medicine; the Indian Herbal Pharmacopoeia (IHP) in its new edition covers 52 monographs on Indian medicinal plants; and the African Herbal Pharmacopoeia (AfrHP) provides comprehensive and up to date botanical, commercial, and phytochemical information on over fifty of the most important African medicinal plants. Many member states of WHO do not possess their own pharmacopoeia, but they follow one or more pharmacopoeia of other nations (e.g., in Australia, herbal raw materials are required to be authenticated to the relevant possible monograph in the British pharmacopoeia). Since 1999, the World Health Organization (WHO) has published 117 herbal monographs in four volumes and also an additional volume (30 monographs, 13 new and 17 adopted from the existing monographs) for the Newly Independent States (NIS) and Countries of Central and Eastern Europe (CCEE) to promote international harmony in the quality control and use of herbal medicines and to serve as models for the development of national formularies. Each of the WHO monographs contains a systematically narrated body of information of about a particular medicinal plant or crude drug on 19 points from (i) Definition, (ii) Synonym to …, (xvii) Dosage forms, (xviii) Posology, and (xix) References. This guideline for herbal monograph contains comprehensive scientific references on quality, safety, and efficacy of medicinal plants, and herbal pharmacopoeia represents qualitative and therapeutic monographs on botanicals. The monographs of WHO, however, should not be regarded as official pharmacopoeial monograph to replace official compendia. Monographs of organized drugs include crude materials of plant and animal origin such as leaves, flowers, fruit, seeds, stems, wood, bark, roots, rhizomes, ergot, ephedra or other parts, and Spanish fly, which may be entire, fragmented, or powdered, while monographs of unorganized drugs include such material as juices, gums, fixed oils, essential oils, latex, resins, fish liver oils, musk, bees’ wax, certain hormones, enzymes, and antitoxins in fresh or dry states.
- WHO guidelines
- Drug quality assurance