Since ancient times, medicinal plants and simpler herbal remedies have been used in India for the treatment and alleviation of various ailments. Although the use of medicinal plants is as old as mankind itself, their controlled application and the isolation and characterization of active substances started in the early nineteenth century. It is a known fact that extractive plant isolates and isolated active substances played a major role in the development of modern pharmacotherapy. Many of the isolated compounds are still used today, or they have served as models for the synthesis of a large number of drugs.
The quality of any final product is ensured by the standard quality of raw materials and the application of validated production processes and procedures on validated equipment. It is similar with herbal remedies, which are made of high-quality herbal raw materials, extractive preparations (extracts and tinctures), and isolates (essential oil and fatty oil).
The basis of high-quality herbal products is plant material of standard quality. Many factors affect the quality of plant material. Regardless of whether the medicinal plants are grown or collected from the wild, biogenetic factors are certainly important (species, variety, and chemotype). The conditions in which a plant grows are air, climate, land, agro-technical measures that are applied during large-scale production (proper sowing, irrigation, fertilisation, control against weeds and pests), and then collection from the wild or harvest of the plantation, transport, proper storage, drying, and grinding. It is very important to educate people on how to deal with the collection of herbal raw materials from spontaneous flora, as well as those who grow the plants, whether they are doing so in conventional or organic conditions of medicinal plant production. Quality control of herbal raw materials is strictly defined and traceable. First, the identification of plant raw materials is approached. Responsible and expert persons in laboratories for pharmaceutical control or in other relevant institutions conduct identification and categorization under a certain number.
The formulation of new herbal products is a process that has strictly defined phases and includes the work of several sectors of the company that is developing products based on medicinal herbs. The dynamics of the process are divided into stages, which are completed by performing a multitude of necessary activities. The formulation of a new phyto-preparation is a process that has strictly defined phases: from the analysis of the literature and market, through the definition of recipes, validation of the production process, quality control of the final product, and the preparation of technological and registration documents.
When the preparation is produced and packed in its primary and secondary packaging, quality testing of the final product is conducted. Quality testing is conducted according to the specifications of the final product. It is necessary to examine the complete health and safety of the preparation. The stability of the active substance is also monitored to determine the expiration date.