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Quality for herbal products in EU.pptx

This document provides guidelines for quality specifications of herbal medicinal products and traditional herbal medicinal products. It discusses guidelines for qualitative and quantitative particulars of active substances, descriptions of manufacturing processes, control of starting materials and finished products, stability testing, and definitions. The guidelines are intended to ensure herbal medicinal products and traditional herbal medicinal products meet quality standards.

Health & Medicine◦
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By:AARTIVATSA MPHARM,2ND SEM (DRA) 2239805
Table of Content: • Introduction and legal basis • Scope • Qualitative and quantitative particulars of active substance of a herbal medicinal product • Description of the manufacturing process • Control of starting materials for the manufacture of the herbal medicinal product/ traditional herbal medicinal product • Control tests on the herbal medicinal product • Stability tests • Definitions • References
Introduction and legal basis: • Guidelines on specifications: test procedures and acceptance criteria for herbal substance, herbal preparation and herbal medicinal product/ traditional herbal medicinal product. • Acc.To Directive 2001/83/EC: HMPs is any medicinal product exclusively containing as active ingredients one or more herbal substances in combination with one or more such herbal preparation. • It also include guidelines for herbal veterinary medicinal product. • THMPs additionally contain, vitamins and minerals- quality , specifications and documentation of each vitamin and mineral should comply with all relevant legislation and guidelines.
• Application for medicinal product for human use should be submitted in format referred to the notice of applicant for human medicinal product in EU and the “Guidelines on the use of CTD format in the preparation of a registration application ofTHMP.” • “The manufacturer information and control of active substance should be supplied using European ASMF.”
Scope: • To cover general quality aspects of HMPs andTHMPs. • The holder of MA shall at least be obliged to comply with the principle and guidelines of GMP for medicinal product and to use only active substance which have been manufactured with detailed guidelines on GMP for active substance. • Guidance for “Manufacturer HMPs” • “Guidelines on Good Agricultural and collection practice (GACP) for starting material of herbal origin.”
Qualitative and quantitative particulars of active substance of a herbal medicinal product: • Definition: • Standard Herbal Substance / Herbal Preparation: are adjusted to a defined content of one or more constituents with known therapeutic activity.This is achieved by adjustment of the herbal substance/herbal preparation with inert excipients or by blending batches of the herbal substance/herbal preparation. • Quantified Herbal Substance/ Herbal Preparation: are adjusted to one or more active markers, the content of which is controlled within a limited, specified range. Adjustments are made by blending batches of the herbal substance/herbal preparation.
• Declaration of the Active Substance:The declaration of the active substance in the documentation and in the product information should be in line with the “Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products”. • Herbal substance and herbal preparation consisting of comminuted or powered herbal substance. • Herbal preparation produced by steps which exceed comminution • Extracts
Description of the manufacturing process: Active Substance: • This should include details of the process together with the controls exercised. Data on manufacturing process development should be added. • The maximum holding times and storage conditions applied. • The selection of a decontamination process should be fully justified on the basis of the type and composition of the herbal material, its intended use and route of administration. • The use of ethylene oxide is prohibited for the decontamination of herbal substances. • Any use of recovered/recycled solvent should be justified.
Herbal Medicinal Products: • the preparation of theTHMP from herbal substance(s) and/or herbal preparations and may include the addition of vitamins and/or minerals. • The maximum holding time and storage conditions of intermediate and bulk products should be stated and supported by stability data. • This section should be in accordance with the “Guideline on manufacture of the finished dosage form”. • Information on development pharmaceutics and process validation should also be provided in accordance with the “Note for guidance on development pharmaceutics” the “ICH Guideline Q8 (R2) on pharmaceutical development”. “Guideline on process validation for finished products - information and data to be provided in regulatory submissions”
Control of starting material for the manufacture of HMPs/THMPs: • Control of Herbal Substance and Herbal Preparation: “Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products” • Control of Herbal Substance: • Control of Herbal Preparation: • Control of vitamins and minerals (if applicable): • Control of excipients:
Control tests carried out at an intermediate stage of the manufacturing process of the herbal medicinal product: • Details of all control tests, with details of test procedures and limits applied at any intermediate stages of the manufacturing processes and/or at stage of the bulk, are required especially if these tests cannot be performed on the HMP
Control tests on the herbal medicinal product: • This section should be in accordance with the “Guideline on specifications and control tests on the finished product”, the “Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products”, and the analytical procedures should be validated according to the “Note for guidance on validation of analytical procedures:Text and methodology”. • The control tests on the finished product7 should allow the qualitative and quantitative determination of the active substance(s) as well as the determination of characteristic properties of the dosage form and the entire finished product including packaging characteristics.
Stability tests: • General principles:This section should be in accordance with the “Note for guidance on stability testing of new drug substances and products” and the “Guideline on stability testing of existing active substances and related finished products” the “Note for guidance on in-use stability testing of human medicinal products”. • The herbal substance/herbal preparation does not have constituent(s) with known therapeutic activity simply determining the stability of active marker(s) or analytical marker(s), will not suffice and a series of stability-indicating tests (e.g. TLC, HPLC) will be needed.The stability of the herbal substance/herbal preparation as a multi-component system, should, as far as possible, also be demonstrated, e.g. by means of appropriate fingerprint chromatograms. It should also be demonstrated that their proportional content remains comparable to the initial chromatographic fingerprint.
• Stability of herbal substances/herbal preparations:Testing at the accelerated storage condition or at the intermediate storage condition may be omitted for herbal substances/herbal preparations, if justified by the applicant and if the storage conditions below 25°C are clearly labelled. • Herbal substances/herbal preparations with constituents of known therapeutic activity:The stability of the constituents with known therapeutic activity should be demonstrated, e.g. by means of appropriate fingerprint chromatograms of these constituents and an assay. • Herbal substances/herbal preparations for which constituents with known therapeutic activity are not known:The stability of active marker(s) or analytical marker(s) should be demonstrated, e.g. by means of appropriate fingerprint chromatograms of these constituents and an assay.
• Active markers: In the retest/shelf-life specification, a variation in the active markers content of ± 5% from the initial batch-specific value is acceptable. If justified, a widening up to ± 10% from the initial batch-specific content could be acceptable. In any case, it has to be ensured that at the end of re-test/shelf-life, the contents for all the active markers remain within the defined ranges. • Analytical markers: In the retest/shelf-life specification, a variation in the analytical markers content of ± 5% of the initial batch-specific value is acceptable. If justified, a widening up to ± 10% from the initial batch-specific content could be acceptable. All analytical markers should remain within the release acceptance criteria, unless otherwise justified.
Stability of herbal medicinal products: Regarding the parameter content, specific characteristics of different types of herbal substances/herbal preparations used as active substances in HMPs should be taken into account. • HMPs containing, as active substances, herbal substances/herbal preparations with constituents of known therapeutic activity: • HMPs containing, as active substances, herbal substances/herbal preparations for which constituents with known therapeutic activity are not known:
Definitions: • Acceptance criteria: Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures. • Chromatographic fingerprinting: Application of chromatographic techniques to create a characteristic chromatographic pattern of phytochemical constituents which represents the multicomponent system typical of the herbal substance/herbal preparation/HMP. • Constituents with known therapeutic activity: are chemically defined substances or groups of substances, which are generally accepted to contribute substantially to the therapeutic activity of a herbal substance, a herbal preparation or a HMP.
• Drug extract ratio (DER): The ratio between the quantity of herbal drug (herbal substance) used in the manufacture of an extract and the quantity of extract obtained.The number (given as the actual range) written before the colon is the relative quantity of the herbal drug; the number written after the colon is the relative quantity of the extract obtained.Two DER can be distinguished: • Genuine (native) drug extract ratio (DERgenuine) • Total drug extract ratio (DERtotal) • Extraction solvents: are solvents, which are used for the extraction process • Markers: are chemically defined constituents or groups of constituents of a herbal substance, a herbal preparation or a herbal medicinal product which are of interest for control purposes independent of whether they have any therapeutic activity. Markers serve to calculate the quantity of herbal substance(s) or herbal preparation(s) in the HMP if the marker has been quantitatively determined in the herbal substance or herbal preparation..
REFERENCE: • https://www.edqm.eu/sites/default/files/medias/fichiers/European_Pharmacopoei a/Find_information_on/Technical_Guides/Technical_Guide_for_the_Elaboration_ of_Monographs_on_herbal_drugs_and_herbal_drug_preparations_2007.pdf • https://www.ema.europa.eu/en/documents/scientific-guideline/final-guideline- quality-herbal-medicinal-products/traditional-herbal-medicinal-products-revision- 3_en.pdf
Quality for herbal products in EU.pptx