GOOD PHARMACOPOEIAL PRACTICES Draft chapter on monographs on herbal medicines
|
|
- Roderick Horn
- 5 years ago
- Views:
Transcription
1 7 September 2017 Draft GOOD PHARMACOPOEIAL PRACTICES Draft chapter on monographs on herbal medicines (DISCUSSED during the 8th international meeting of world pharmacopoeias, terminology added 7/9/2017) Please address any comments on this proposal by 5 October 2017 to Dr S. Kopp, Group Lead, Medicines Quality Assurance, World Health Organization, 1211 Geneva 27, Switzerland, fax: (+41 22) or kopps@who.int with a copy to finnertyk@who.int World Health Organization 2017 All rights reserved. This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and member organizations) without the permission of the World Health Organization. The draft should not be displayed on any web site. Please send any request for permission to: Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, Regulation of Medicines and other Health Technologies, Department of Essential Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) ; kopps@who.int. The designations employed and the presentation of the material in this draft do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This draft does not necessarily represent the decisions or the stated policy of the World Health Organization.
2 page SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/15.621: GOOD PHARMACOPOEIAL PRACTICES CHAPTER ON MONOGRAPHS ON HERBAL MEDICINES/DRUGS Need for good pharmacopoeial practices (GPhP) stated during first international meeting of world pharmacopoeias, Geneva, and other related events with stakeholders 28 February 1 March October October October October 2012 First draft of good pharmacopoeial practices (GPhP) sent out for comment (QAS/12.516) Compilation of feedback and comments received November December 2012 Circulation of GPhP to drafting group on GPhP with 18 January 2013 comments, as well as Concept paper on scope and background (QAS/13.518) Formation of initial drafting group (IDG), including February 2013 representatives from each pharmacopoeia, as per selfnomination, to review draft concept paper via teleconference call Preparation of new skeleton and first draft with more detailed February 2013 structure Mailing to world pharmacopoeias for additional feedback, February March 2013 preparation of draft chapters by drafting group Compilation of feedback April 2013 Discussion of draft working document on good pharmacopoeial practices at second international meeting of April 2013 world pharmacopoeias, New Delhi, India Revised version of GPhP prepared and mailed out for 28 May 2013 comments to all pharmacopoeias, for feedback to be provided to lead pharmacopoeias for each chapter Discussion of feedback during informal consultation to June 2013 discuss new medicines, quality control and laboratory standards Revision of each chapter by each GPhP lead pharmacopoeia 28 June 2013 Mailing of each chapter to WHO for compilation into a revised working document Presentation to forty-eighth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations Compilation of all various chapters received from the lead pharmacopoeias and mailing out to all world pharmacopoeias July 2013 December 2013 October 2013 January 2014
3 page 3 Compilation of all comments received March 2014 Discussion during the 3rd international meeting of world April 2014 pharmacopoeias in London, United Kingdom Revised version of GPhP prepared and mailed out for July 2014 comments to all pharmacopoeias, for feedback to be provided to each chapter Compilation of all comments received 22 September 2014 Following feedback and discussions during two telephone 23 September 2014 conference calls of the subgroup working on the Technical Annex to the future GPhP the European Pharmacopoeia Secretariat prepared a significantly shortened draft which is circulated for comments Compilation of all comments received 30 September 2014 Discussion during the 4th international meeting of world pharmacopoeias in Strasbourg, France Briefing on progress to forty-ninth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations Continuation of consultation process with world pharmacopoeias Continuation of consultation process with world pharmacopoeias and worldwide 8 10 October October 2014 October 2014 January 2015 Mid-January mid-march 2015 GPhP Chapter 5.4.2: Monographs on Herbals April 2013 medicines/drugs drafted by the Indian Pharmacopoeia Committee (IPC) Comments received by pharmacopoeias and track change proposals made by USP 2014 Additional feedback received from various pharmacopoeias to GPhP Chapter 5.4.2: Monographs on herbals March 2015 Comments reviewed and feedback added by IPC April 2015 Working document sent out to all pharmacopoeias for May 2015 comments and feedback Compilation of comments received August 2015 Discussion of feedback during the 6th international meeting of world pharmacopoeias September 2015, dates tbc with the Chinese Pharmacopoeia Commission 3
4 page 4 Presentation to the fiftieth meeting of the WHO Expert October 2015 Committee on Specifications for Pharmaceutical Preparations Comments reviewed and feedback added by IPC April 2016 Working document sent out to all pharmacopoeias for May June 2016 comments and feedback Compilation of comments received and inclusion of proposed July August 2016 changes by WHO Secretariat + mailing of feedback and new draft to all pharmacopoeias Discussion of feedback during the 7th international meeting September 2016 of world pharmacopoeias Working document sent out to all pharmacopoeias for September 2016 comments and feedback Presentation to the fifty-first meeting of the WHO Expert October 2016 Committee on Specifications for Pharmaceutical Preparations Working document sent out (Rev. 2) to all pharmacopoeias November 2016 for comments and feedback Compilation of comments received March May 2017 Discussion of feedback during the 8th international meeting of world pharmacopoeias Circulation to world pharmacopoeias and for public feedback, addition of glossary after the Third WHO consultation on quality control of herbal medicines planned to be held in Hong Kong SAR, China, 4-6 September 2017, during which the Good Herbal Processing Practices with related terminology will be discussed added 7/9/2017 Presentation to the fifty-second meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations July 2017 July September October 2017 Any follow-up action as necessary
5 page MONOGRAPHS ON HERBAL MEDICINES 1. INTRODUCTION Pharmacopoeial monographs for herbal medicines should contain information in the definition that is consistent with the monograph title followed by specifications for quality including identity, purity and content. Individual monographs describe test procedures together with the corresponding specifications. The monograph may include: an official title; a definition; an identification section; a test section covering, for example, physicochemical tests and, where appropriate, tests on contaminants; an assay section determining constituents with known therapeutic activity, active or analytical markers. Further sections providing information on labelling and storage may also be provided. 2. GENERAL CHAPTER The general testing methods and other specifications that are common for herbal medicines may be described in a General Chapter. 3. INDIVIDUAL MONOGRAPHS ON HERBAL MEDICINES 3.1 Monograph title The title of the monograph may include the Latin name, or the well-established common local name and English common name, if available, in addition to the scientific name. 5
6 page This is followed by the name of plant part(s) or plant material (e.g. resin, gum-resin) and where applicable, its state and type of herbal preparation (e.g. liquid extract, dry extract) and its dosage form (tablet, capsule, etc.). Individual pharmacopoeias may apply their own nomenclature policies that meet regulatory needs and reflect the common names in commerce, as appropriate. 3.2 Definition The definition provides details about the subject of the monograph and includes the Latin binomial name and the taxonomic authority (abbreviation if used should be according to internationally-accepted rules), the plant family name if required by national legislations, the well-established common local name and English common name (if available, in addition to the scientific name), and well-recognized synonyms, the plant part(s) (i.e. aerial parts, root, leaves, flowers, rhizome, etc.), plant material (e.g. resin, gum-resin and where applicable, its state and type of herbal preparation (e.g. liquid extract, dry extract) and its dosage form (tablet, capsule, etc.). When necessary, as dictated and supported by data, the definition also states the season or period in which plant material should be harvested according to Good Agricultural and Collection Practices (GACP). If more than one species is included in the monograph the definition should include, for each of the species, the requirements listed above. The definition should include the chemical names, and/or molecular formulas of relevant known constituents, for which there is a specified range or minimum content, in percentage, usually calculated on the basis of the dry weight of the herbal medicines. Where a monograph applies to the herbal medicines in different states or stages of processing (DEFINE STATES IN GLOSSARY, including ), this is stated in the definition. 3.3 Identification The purpose of the Identification section is to ensure that the herbal medicine under examination is in agreement with what is stated in the Definition section. It is only necessary to include those techniques that are applicable for the identification of specific
7 page herbal medicines. Macroscopic and microscopic descriptions of a herbal medicine may be supported by illustrations. Identification tests should be specific for the herbal medicine. Typically, several identification tests, using independent approaches, are required in order to confirm the identity of the herbal medicine. The tests given in the identification section are not designed to give a full confirmation of the chemical structure or composition of the herbal medicine. They are intended to give confirmation, with an acceptable degree of assurance, that the herbal medicine is the one stated on the label. Test methods, if applicable, should be able to detect substitutes or adulterants that are likely to be found. [Note from Secretatriat: Definition for Adulterant in TRS 1003, Annex 1: Adulterant is herbal material, a herbal constituent or other substance that is either deliberately or non-intentionally (through cross-contamination or contamination) added to a herbal material, herbal preparation, or finished herbal product.] Macroscopic characters The important macroscopic botanical characteristics of the herbal materials are specified to permit a clear identification. Where two or more species of a genus or subspecies are included in the definition, the differences, if any, between them should be indicated Microscopic characters The microscopic examination of herbal materials is useful in determining the identity of herbal materials. Histological characters, such as microscopic characters of a transverse or longitudinal section may support the identification. For herbal materials where macroscopic identification cannot be performed (for example, powdered herbal materials), the microscopic characters are important to determine the identity. 7
8 page Chemical tests Chemical tests, such as colour tests, can also be useful in determining the presence of substitution, adulteration or other foreign matters. Non-specific chemical tests must be avoided. Phytochemical screening tests that recognize general classes of compounds such as alkaloids, flavonoids, terpenes, steroids, saponins, tannins, etc., must be avoided unless they provide a means to differentiate potential adulteration due to species substitution/adulteration Fingerprinting Chromatographic or spectroscopic patterns, often referred to as fingerprints, may be used for identification as appropriate. The fingerprints should ideally be able to distinguish the herbal materials from other species that constitute both intentional and unintentional adulterations. Fingerprints may be obtained, for example, by thin-layer chromatography (TLC), highperformance thin-layer chromatography (HPTLC), high-performance liquid chromatography (HPLC), ultra-high performance liquid chromatography (UHPLC), capillary electrophoresis (CE) or gas chromatography (GC) methods. The methods should include all of the information required to perform the test, for example, preparation of sample and reference solutions, nature of plates/columns, testing conditions, mobile phase preparation, flow rate, method of detection/detectors. The results of such testing to be considered must contain a description of the critical features of the fingerprint chromatograms such as the presence of specific peaks or bands/spots, relative retentions or relative retention values, retardation or retention factor (R F or R f ), their order of elution and, where applicable, their relative abundance. A colour image of a typical reproducible TLC fingerprint may be provided as a guide for users. Pharmacopoeias may consider providing reference standards (RS) to be used for fingerprint testing.
9 page DNA-based tests The DNA-based tests, such as PCR and DNA sequencing, can be useful in identifying specific herbal materials or detecting adulteration with either related or unrelated species that are difficult to distinguish with other methods. 3.4 Assay Where the constituent(s) responsible for therapeutic activity of the herbal medicine is/are known, its/their quantitative determination should be included. In herbal medicine where the chemical constituent(s) responsible for known pharmacological/therapeutic activity is/are not known, the pharmacopoeia may include testing for determination of the chemical constituent that act as analytical marker(s). Individual pharmacopoeias may include an assay procedure for one or more marker compounds. Where an assay of one or more chemical constituents is carried out, assay limits are specified either as a minimum content or as a percentage content range. Where constituents are present in a herbal medicine which are known to degrade (e.g. due to improper drying, storage under high temperatures or extended storage), those constituents may be used as analytical markers to control the quality of the herbal medicine. Stability-indicating chromatographic procedures that are validated for routine quality control work should be used. Individual pharmacopoeias may adopt either requirement for validation of assay methods on lines similar to those adopted for chromatographic procedures for synthetic drugs or developing assay methods. Development of assay methods through a collaborative process involving several laboratories, or other suitable approaches, may be adopted. 3.5 Tests for contaminants/impurities General Tests for the following parameters should be included and limits specified as appropriate: 9
10 page foreign matter; elemental contaminants/impurities (for, e.g. toxic metals such as lead, cadmium, mercury and arsenic); microbiological quality: national pharmacopoeias may consider specifying requirements for total aerobic microbial count (TAMC) and total combined yeast/moulds count (TYMC) as well as for specified microorganisms, for example, bile-tolerant gram negative bacteria, Escherichia coli and Salmonella; mycotoxins; toxic/harmful substances (such as pesticide residues, radionuclides and natural toxins); residual solvents Specific An individual herbal medicine may require specifications that are peculiar to that item, especially when patient safety is an issue. Limits should be set on certain constituents of the herbal medicines that may be considered undesirable negative markers, negative botanic characteristics or histological parameters. Impact on safety/description may form the basis for such test and limits are specified. For some individual herbal medicines, there could be risk of adulteration by herbal medicines that have a related morphological appearance or are marketed under similar common names. In such cases, additional tests as appropriate may be specified to detect and determine such adulterants. Where appropriate, tests on compounds (like alkaloids or cardiotonic steroids, etc.) that may impact the safety of the herbal medicines may be included in the monograph.
11 page Physicochemical tests Physicochemical tests can serve as a valuable source of information and provide appropriate characterization standards to establish the quality of herbal medicines. Such evaluations may include: water and/or alcohol extractable matter; total ash content; water soluble ash; alcohol-soluble ash; acid-insoluble ash; loss on drying; water content; volatile oils, etc. 3.7 Other tests The following tests may be included as appropriate: swelling index; bitterness values; particle size; or any other test(s) found appropriate to the particular herbal medicine or material. Taste and/or odour as definitions or test procedures may be inappropriate for user safety reasons and should be avoided. 3.8 Additional information Packaging, labelling and storage 1
12 page Labelling requirements consistent with applicable national/regional legislation may be provided. Storage conditions may be provided when considered necessary to prevent contamination and/or are necessary to minimize possible deterioration. Guidance statements specifying the packaging may be included in the monograph, in specific cases, where applicable, for example, oils or oleoresins or distilled oils Reference standards The pharmacopoeias may describe the use of reference standards in the analysis of individual herbal medicines. RS may be authentic pure compounds or extracts of herbal materials or powdered herbal materials used for comparison. The RS established by individual pharmacopoeias are suitable for testing purposes. GLOSSARY [Note from the Secretariat: The following terms relating to herbal medicines have been redefined in connection with the development of new WHO guidelines in the area of good practices for herbal medicines. The following may serve for the Glossary, but were not yet agreed upon by the world pharmacopoeias during the 2016 meeting in Tokyo, Japan. During the 8th meeting in Brasilia it was agreed to add the glossary after the Third WHO consultation on quality control of herbal medicines planned to be held in Hong Kong SAR, China, 4 6 September 2017 during which the Good Herbal Processing Practices and related terminology will be discussed and recirculate the text thereafter. 7/9/2017, please find the terminology agreed upon in that meeting included below] Herbal medicines include herbs and/or herbal materials and/or herbal preparations and/or finished herbal products in a form suitable for administration to patients. [WHO, 2017]
13 page Note: In some countries herbal medicines may contain, by tradition, natural organic or inorganic active ingredients that are not of plant origin (e.g. animal and mineral materials, fungi, algae, lichens, etc). Herbs [WHO, 2000] Herbs include crude plant materials such as leaves, flowers, fruit, seed, stems wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered. Herbal materials [WHO 2000]* Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins, and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting, or stirbaking with honey, alcoholic beverages or other plant materials. * The participants of the 3 rd WHO consultation on quality control, held in Hong Kong SAR, China from 4 to 6 September 2017 recommended that latex and exudates can be included. Herbal preparations [WHO, 2000] Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials. They are produced by extraction, fractionation, purification, concentration, or other physical or biological processes. They also include preparations made by steeping or heating herbal materials in alcoholic beverages and/or honey, or in other materials. Finished herbal products [WHO, 2017] Finished herbal products consist of one or more herbal preparations made from one or more herbs (i.e. from different herbal preparations made of the same plant as well as herbal preparations from different plants. Products containing different plant materials are called mixture herbal products ). 1
14 page Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. However, finished products or mixture herbal products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal. Herbal dosage forms Herbal dosage forms are the physical form (liquid, solid, semi-solid) of herbal products produced from herbs, with or without excipients, in a particular formulation (such as decoctions, tablets, and ointments). They are produced either from herbal materials (such as dried roots or fresh juices) or herbal preparations (such as extracts). Medicinal plants are plants (wild or cultivated) used for medicinal purposes [WHO, 2003a]; [WHO, 2006; WHO, 2007a]. Medicinal plant materials: see Herbal materials State [QAS/15.621/Rev.2] The state of the herbal material means whole, fragmented, peeled, cut, fresh or dried. ***
Good pharmacopoeial practices: Chapter on monographs on herbal medicines
Annex 7 Good pharmacopoeial practices: Chapter on monographs on herbal medicines Background Following the fiftieth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations,
More informationGOOD PHARMACOPOEIAL PRACTICES
May 2013 RESTRICTED GOOD PHARMACOPOEIAL PRACTICES CONCEPT PAPER ON PURPOSE AND BENEFITS (MAY 2013) DRAFT FOR COMMENT Please address any comments on this proposal by 12 July 2013 to Dr S. Kopp, Medicines
More information2. Selection criteria for substances of herbal origin relevant for standardization and quality control of herbal medicines 77
Annex 1 WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines 1. Introduction 72 1.1 Background 72 1.1.1 Preparation of the document 73 1.2 Objectives
More informationRevision of monograph in the 4 th Edition of The International Pharmacopoeia (August 2008)
August 2008 RESTRICTED MEBENDAZOLE Revision of monograph in the 4 th Edition of The International Pharmacopoeia (August 2008) REVISED DRAFT FOR ADOPTION This document was provided by a quality control
More informationDRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA: CARBAMAZEPINI COMPRESSI - CARBAMAZEPINE TABLETS
December 2015 Draft document for comment 1 2 3 4 5 6 DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA: CARBAMAZEPINI COMPRESSI - CARBAMAZEPINE TABLETS (December 2015) REVISED DRAFT FOR COMMENT Should
More informationCYCLOSERINI CAPSULAE - CYCLOSERINE CAPSULES (AUGUST 2015)
August 2015 Document for comment 1 2 3 4 5 CYCLOSERINI CAPSULAE - CYCLOSERINE CAPSULES DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA (AUGUST 2015) DRAFT FOR COMMENT 6 Should you have any comments
More informationSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS Draft proposal for The International Pharmacopoeia (September 2010)
September 2010 RESTRICTED SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS Draft proposal for The International Pharmacopoeia (September 2010) REVISED DRAFT FOR COMMENT This document was provided by a quality
More informationPROPOSAL FOR REVISION OF MONOGRAPH PUBLISHED IN The International Pharmacopoeia: REVISION OF ph test ABACAVIR ORAL SOLUTION (JULY 2012)
July 2012 RESTRICTED PROPOSAL FOR REVISION OF MONOGRAPH PUBLISHED IN The International Pharmacopoeia: REVISION OF ph test ABACAVIR ORAL SOLUTION (JULY 2012) PROPOSED REVISION FOR COMMENT The background
More informationLEVONORGESTREL AND ETHINYLESTRADIOL TABLETS. (January 2012) DRAFT FOR COMMENT
January 2012 RESTRICTED DRAFT PROPOSAL FOR The International Pharmacopoeia LEVONORGESTREL AND ETHINYLESTRADIOL TABLETS (January 2012) DRAFT FOR COMMENT This document was provided by a quality control expert.
More informationDRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA EFAVIRENZ, EMTRICITABINE AND TENOFOVIR TABLETS
September 2010 RESTRICTED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA EFAVIRENZ, EMTRICITABINE AND TENOFOVIR TABLETS (August 2010) DRAFT FOR COMMENT This document was provided by a quality control
More informationCLINDAMYCIN PALMITATE
February 2018 Document for comment 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 CLINDAMYCIN PALMITATE POWDER FOR ORAL
More informationEMTRICITABINE AND TENOFOVIR TABLETS
September 2010 RESTRICTED EMTRICITABINE AND TENOFOVIR TABLETS Draft proposal for The International Pharmacopoeia (September2010) REVISED DRAFT FOR COMMENT This document was provided by a quality control
More informationABACAVIR SULFATE Proposal for revision of The International Pharmacopoeia (August 2012)
August 2012 RESTRICTED ABACAVIR SULFATE Proposal for revision of The International Pharmacopoeia (August 2012) Draft for comment This document was provided by a quality control expert. Should you have
More informationDraft monograph for inclusion in. The International Pharmacopoeia. Dextromethorphani solutionum peroralum - Dextromethorphan oral solution
August 2015 Draft document for comment 1 2 3 4 5 6 Draft monograph for inclusion in The International Pharmacopoeia Dextromethorphani solutionum peroralum - Dextromethorphan oral solution (August 2015)
More informationZIDOVUDINE, LAMIVUDINE AND ABACAVIR TABLETS Draft proposal for The International Pharmacopoeia (September 2006)
September 2006 RESTRICTED ZIDOVUDINE, LAMIVUDINE AND ABACAVIR TABLETS Draft proposal for The International Pharmacopoeia (September 2006) This document was provided by a contracted quality control laboratory.
More informationDRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA PAEDIATRIC RETINOL ORAL SOLUTION (August 2010)
August 2010 RESTRICTED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA PAEDIATRIC RETINOL ORAL SOLUTION (August 2010) DRAFT FOR COMMENT This document was provided by a quality control expert and was
More informationQUALITY OF HERBAL REMEDIES
QUALITY OF HERBAL REMEDIES Guideline Title Quality of Herbal Remedies Legislative basis Directive 75/318/EEC as amended Date of first adoption November 1988 Date of entry into May 1989 force Status Last
More informationQUALITY OF HERBAL MEDICINAL PRODUCTS: PRESENT REQUIREMENTS
QUALITY OF HERBAL MEDICINAL PRODUCTS: PRESENT REQUIREMENTS Phytopharm 2015 Bonn, 21 24 July 2015 1 Dr. Barbara Steinhoff Bundesverband der Arzneimittel-Hersteller CONTENTS Production of herbal starting
More informationINTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LAMIVUDINE TABLETS
RESTRICTED INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LAMIVUDINE TABLETS DRAFT FOR COMMENT Please address any comments you may have on this document, by 12 July 2006, to Dr S. Kopp, Quality Assurance and
More informationREVISED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA RETINOL CONCENTRATE, OILY FORM. (August 2010)
August 2010 RESTRICTED REVISED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA RETINOL CONCENTRATE, OILY FORM (August 2010) DRAFT FOR COMMENT This document was provided by a quality control expert
More informationIMPLEMENTATION OF THE REVISED GENERAL
July 2013 RESTRICTED 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 IMPLEMENTATION OF THE REVISED GENERAL MONOGRAPH ON PARENTERAL
More informationANNEX III ASEAN GUIDELINES ON LIMITS OF CONTAMINANTS FOR TRADITIONAL MEDICINES
Association of South East Asian Nations (ASEAN) ANNEX III ASEAN GUIDELINES ON LIMITS OF CONTAMINANTS FOR TRADITIONAL MEDICINES Disclaimer: This document is provided for information purpose only and subject
More informationGuideline on quality of herbal medicinal products 1 /traditional herbal medicinal products
31 March 2011 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Committee on Herbal Medicinal Products (HMPC) Guideline on quality of herbal
More informationEUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 01 September 2008 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4
More informationDiscussion by HMPC Drafting Group on Quality February Start of public consultation 27 June 2012
1 2 3 22 May 2012 EMA/HMPC/312890/2012 Committee on Herbal Medicinal Products (HMPC) 4 5 6 7 8 Concept paper on non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal
More informationASEAN GUIDELINES ON LIMITS OF CONTAMINANTS FOR TRADITIONAL MEDICINES (TM) AND HEALTH SUPPLEMENTS (HS)
Association of South East Asian Nations (ASEAN) ASEAN GUIDELINES ON LIMITS OF CONTAMINANTS FOR TRADITIONAL MEDICINES (TM) AND HEALTH SUPPLEMENTS (HS) Version 3.0 CONTENTS 1. Introduction...2 2. Objective...
More informationCYCLOSERINE Proposal for revision of The International Pharmacopoeia (August 2012)
August 2012 RESTRICTED CYCLOSERINE Proposal for revision of The International Pharmacopoeia (August 2012) Draft for comment This document was provided by a quality control expert. Should you have any comments
More informationEUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 16 March 2006 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU
More informationH e r b a l M e dicines' Q U A L I T Y M ANUAL. I. Introduction
INTRODUCTION To the Recommendation by the Board of the Eurasian Economic Commission Dated 20 No H e r b a l M e dicines' Q U A L I T Y M ANUAL I. Introduction 1. The Herbal Medicines Quality Manual (hereinafter
More informationGuideline on quality of herbal medicinal products 2 /traditional herbal medicinal products
1 2 3 4 5 05 June 2018 EMA/HMPC/201116/2005 1 Rev. 3 Committee on Herbal Medicinal Products (HMPC) Guideline on quality of herbal medicinal products 2 /traditional herbal medicinal products DRAFT Revision
More informationDRAFT PROPOSAL FOR REVISION OF GENERAL MONOGRAPHS: PARENTERAL PREPARATIONS. (July 2012) Draft for comment
1 2 3 4 5 DRAFT PROPOSAL FOR REVISION OF July 2012 RESTRICTED GENERAL MONOGRAPHS: PARENTERAL PREPARATIONS (July 2012) Draft for comment This document was provided by a quality control expert. Should you
More informationEuropean Medicines Agency COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL
European Medicines Agency London, 12 November 2009 Doc. Ref. EMEA/HMPC/67644/2009 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL GUIDELINE ON SELECTION OF TEST MATERIALS FOR GENOTOXICITY TESTING FOR
More informationMEDICNES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL PRODUCTS IN THE GAMBIA
MEDICNES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL PRODUCTS IN THE GAMBIA Document No.: MCA/HMPG/17/12/01 Date of Adoption: 20 th January 2017 Date of Issue: 25 th July 2017 Version
More informationINTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE
RESTRICTED INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE REVISED DRAFT FOR DISCUSSION World Health Organization 2007 All rights reserved. This draft is intended for a restricted
More informationGeneral Concepts in the European Pharmacopoeia. Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe
General Concepts in the European Pharmacopoeia Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe General notices Anne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All
More informationDiscussion by HMPC Drafting Group on Quality September Start of public consultation 15 February 2013
1 2 3 15 January 2013 EMA/HMPC/13658/2013 Committee on Herbal Medicinal Products (HMPC) 4 5 6 7 Concept paper on use of recovered/recycled solvents in the manufacture of herbal preparations for use in
More informationAD HOC WORKING GROUP ON HERBAL MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use 28 January 1999 EMEA/HMPWP/16/99 AD HOC WORKING GROUP ON HERBAL MEDICINAL PRODUCTS Final Comments for
More informationGuideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products 1
1 2 3 8 August 2012 EMA/HMPC/71049/2007 Rev. 1 Committee on Herbal Medicinal Products (HMPC) 4 5 6 7 Guideline on the use of the CTD format in the preparation of a registration application for traditional
More informationWHO guidelines on good manufacturing practices (GMP) for herbal medicines
WHO guidelines on good manufacturing practices (GMP) for herbal medicines Contents Contents Acknowledgements...v Preface...vii Section I...1 WHO good manufacturing practices (GMP): updated supplementary
More informationDraft proposal for The International Pharmacopoeia
April 2012 RESTRICTED SULFAMETHOXAZOLE AND TRIMETHOPRIM INTRAVENOUS INFUSION Draft proposal for The International Pharmacopoeia (April 2012) DRAFT FOR COMMENT This document was provided by a quality control
More informationDETERMINATION OF MICROBIAL CONTAMINANTS IN SOME MARKETED HERBAL FORMULATION
DETERMINATION OF MICROBIAL CONTAMINANTS IN SOME MARKETED HERBAL FORMULATION INTRODUCTION: Herbal medicines are in great demand in the developed as well as developing countries for primary health care because
More informationProf. Marina Heinonen University of Helsinki Member of the NDA Panel and EFSA s WG on Novel Foods
Guidance on Novel Foods Composition, production process and specification Prof. Marina Heinonen University of Helsinki Member of the NDA Panel and EFSA s WG on Novel Foods Info-Session 06 March 2017 Parma
More informationLegal Requirements for the Control of Contaminants in Herbal Medicinal Products and Related Areas
Legal Requirements for the Control of Contaminants in Herbal Medicinal Products and Related Areas AOAC International Workshop Erlangen, 11 October 2011 Dr. Barbara Steinhoff Contents Heavy metals Microorganisms
More informationDiscussion at the HMPC January March Draft agreed by Quality Working Party April Adoption by CHMP for release for consultation 26 May 2005
1 2 3 4 5 05 June 2018 EMA/HMPC/162241/2005 1 Rev. 3 6 7 8 9 Guideline on specifications: test procedures and acceptance criteria for herbal substances 2, herbal preparations 3 and herbal 4 /traditional
More informationUSP Dietary Supplements Standards Up-to-Date Roundtable Meeting Report. Huy Dinh, MS. Senior Scientific Liaison Dietary Supplements
1 USP Dietary Supplements Standards Up-to-Date Roundtable Meeting Report Huy Dinh, MS. Senior Scientific Liaison Dietary Supplements Roundtable s objectives Foster discussion among the participants to
More informationDIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 31 March 2004
30.4.2004 Official Journal of the European Union L 136/85 DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending, as regards traditional herbal medicinal products,
More informationGuide. homoeopathic preparations. for the elaboration of monographs on
Guide for the elaboration of monographs on homoeopathic preparations " Stocks for homoeopathic preparations may be of mineral, chemical, botanical, zoological or human origin European Pharmacopoeia Homoeopathic
More informationFormulation stability studies. 9.1 OBJECTIVE To monitor the stability of the developed herbal formulations using the limited and specific methods.
9.1 OBJECTIVE To monitor the stability of the developed herbal formulations using the limited and specific methods. 9.2 INTRODUCTION The legal definition of stability is aimed at assuring that the drug
More informationREGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011.
REGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011. CHAPTER I Scope and definitions. Article 1 Scope.
More informationHERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK. Presented by: Mariam Aslam
HERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK Presented by: Mariam Aslam ESCOP European Scientific Cooperative On Phytotheapy (ESCOP) Founded in June 1989 as an umbrella
More informationDRS RWANDA STANDARD. Spirulina products Specification. Part 1: Ground spirulina. First edition mm-dd. Reference number DRS 359-1: 2017
RWANDA STANDARD DRS 359-1 First edition 2017-mm-dd Spirulina products Specification Part 1: Ground spirulina Reference number DRS 359-1: 2017 RSB 2017 In order to match with technological development and
More informationREVISED DRAFT FOR COMMENTS
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 WHO/SDS/TCM R-Draft WHO guidelines for comments March 2017 Distribution: Restricted
More informationSHRI GURU RAM RAI INSTITUTE OF TECHNOLOGY AND SCIENCE
STANDARDIZATION OF HERBAL PRODUCTS Herbal drug, the naturally of mankind since ages in combating various diseases has received a raw deal from the practitioners of the modern medicine due to many reasons.
More informationTENOFOVIRI DISOPROXILIS FUMARAS TENOFOVIR DISOPROXIL FUMARATE
August 2009 RESTRICTED TENOFOVIRI DISOPROXILIS FUMARAS TENOFOVIR DISOPROXIL FUMARATE DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA FOR COMMENT Please send any comments on this document to Dr S. Kopp
More informationPROPOSAL FOR REVISION OF MONOGRAPH IN THE FOURTH EDITION OF The International Pharmacopoeia MEFLOQUINE HYDROCHLORIDE (JANUARY 2012) DRAFT FOR COMMENT
January 2012 RESTRICTED PROPOSAL FOR REVISION OF MONOGRAPH IN THE FOURTH EDITION OF The International Pharmacopoeia MEFLOQUINE HYDROCHLORIDE (JANUARY 2012) DRAFT FOR COMMENT This document was provided
More informationUSP botanical quality standards: contributions in quality control & safe use of botanicals
USP botanical quality standards: contributions in quality control & safe use of botanicals Hellen Oketch-Rabah, PhD Senior Scientific Liaison, Dietary Supplements, Herbal Medicines UNITED STATES PHARMACOPEIA
More informationOrganic Impurities in Drug Substances and Drug Products. Antonio Hernandez-Cardoso, M.Sc. Senior Scientific Liaison September 8, 2017
Organic Impurities in Drug Substances and Drug Products Antonio Hernandez-Cardoso, M.Sc. Senior Scientific Liaison September 8, 2017 Potential sources of drug impurities during development AAPS PharmSciTech,
More informationCLINDAMYCIN PHOSPHATE (CLINDAMYCINI PHOSPHAS) REVISED DRAFT MONOGRAPH FOR INCLUSION IN The International Pharmacopoeia (August 2016)
August 2016 Draft for comments 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 CLINDAMYCIN PHOSPHATE (CLINDAMYCINI PHOSPHAS)
More informationSafety Assessment of Botanicals and Botanical Preparations. Dr. Balasubramanian
Safety Assessment of Botanicals and Botanical Preparations Dr. Balasubramanian Introduction Plant materials and extracts (botanicals) form a major component in indigenous peoples traditional ingredients
More informationPROPOSAL FOR REVISION OF MONOGRAPH PUBLISHED IN THE FOURTH EDITION OF The International Pharmacopoeia
August 2011 RESTRICTED PRPSAL FR REVISIN F MNGRAP PUBLISED IN TE FURT EDITIN F The International Pharmacopoeia ARTESUNATE (August 2011) PRPSED REVISIN FR CMMENT Should you have any comments on the attached
More informationEuropean Union legislation on Food additives, Food enzymes, Extractions solvents and Food flavourings
European Union legislation on Food additives, Food enzymes, Extractions solvents and Food flavourings European Commission, DG, Unit E3 Chemicals, contaminants and pesticides Serbia-Screening meeting on
More informationSavesta Herbals is engaged in manufacturing
Savesta Herbals is engaged in manufacturing standardized herbal extracts that synergistically combine the ancient wisdom of Ayurveda with the modern production and QC methods. Our state-of- the- art production
More informationExtraction and Standardization of Medicinal Herbal Products
Extraction and Standardization of Medicinal Herbal Products By: Dr Masoud Sadeghi Dinani Department of Pharmacognosy Isfahan University of Medical Sciences Medicinal Plants About 80% of all the world s
More informationCOMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL PROCEDURE FOR THE PREPARATION OF COMMUNITY MONOGRAPHS FOR TRADITIONAL HERBAL MEDICINAL PRODUCTS
European Medicines Agency Evaluation of Medicines for Human Use London, 11 January 2007 Ref: EMEA/HMPC/182320/2005 Rev. 2 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL PROCEDURE FOR THE PREPARATION
More informationGuidance notes on the classification of food extracts with colouring properties Last update [ ]
DOES NOT NECESSARILY REPRESENT THE OFFICIAL VIEWS OF THE COMMISSION Guidance notes on the classification of food extracts with colouring properties Last update [28.10.2013] Contents 1. Purpose, definitions
More informationISO 4731 INTERNATIONAL STANDARD. Oil of geranium (Pelargonium X ssp.) Huile essentielle de géranium (Pelargonium X ssp.) Second edition
INTERNATIONAL STANDARD ISO 4731 Second edition 2006-01-15 Oil of geranium (Pelargonium X ssp.) Huile essentielle de géranium (Pelargonium X ssp.) Reference number ISO 4731:2006(E) ISO 2006 ISO 4731:2006(E)
More informationGuidance on Limits of Foreign Matter in Herbal Ingredients
Guidance on Limits of Foreign Matter in Herbal Ingredients October 2017 Prepared by the American Herbal Products Association This document is the property of the American Herbal Products Association (AHPA)
More informationthe Fiji Kava Piper methysticum Forst. f. Standard
the Fiji Kava Piper methysticum Forst. f. Standard 2017 the Fiji Kava Piper methysticum Forst. f. Standard 2017 Prepared, printed and distributed with assistance from the Australian Government and New
More informationSweetpotato puree - specification
KENYA STANDARD ICS Sweetpotato puree - specification KES 2018 First Edition KENYA STANDARD ICS TECHNICAL COMMITTEE REPRESENTATION The following organizations were represented on the Technical Committee:
More informationRecent Evolution of Monographs for Dietary Supplements in USP
Recent Evolution of Monographs for Dietary Supplements in USP Gabriel Giancaspro, Ph.D. Director for Dietary Supplements Documentary Standards Development USP Irvine CA, October 7, 2011 About USP USP Founded
More informationThe International Pharmacopoeia TENOFOVIR DISOPROXIL FUMARATE (JULY 2012)
July 2012 RESTRICTED PROPOSAL FOR REVISION OF MONOGRAPH PUBLISHED IN THE FOURTH EDITION OF The International Pharmacopoeia TENOFOVIR DISOPROXIL FUMARATE (JULY 2012) PROPOSED REVISION FOR COMMENT This document
More informationStandardization of Milagathi Choornam
2014; 1 (6): 69-74 ISSN 2321-2187 IJHM 2014; 1 (6): 69-74 Received: 19-12-2013 Accepted: 16-01-2014 Priya F Government Siddha Medical College, Anna Hospital Campus, Shakila R Siddha Central Research Institute
More informationGUIDANCE FOR SAMPLING ART CLINICS IN COUNTRIES COMBINING SURVEILLANCE OF PRE-TREATMENT HIV DRUG RESISTANCE AND ACQUIRED HIV DRUG RESISTANCE AT 12 AND
GUIDANCE FOR SAMPLING ART CLINICS IN COUNTRIES COMBINING SURVEILLANCE OF PRE-TREATMENT HIV DRUG RESISTANCE AND ACQUIRED HIV DRUG RESISTANCE AT 12 AND 48+ MONTHS DECEMBER 2017 Guidance For Sampling ART
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 4716 Third edition 2013-08-01 Essential oil of vetiver [Chrysopogon zizanioides (L.) Roberty, syn. Vetiveria zizanioides (L.) Nash] Huile essentielle de vétiver [Chrysopogon
More informationGuideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products 1
5 April 2016 EMA/HMPC/71049/2007 Rev. 2 Committee on Herbal Medicinal Products (HMPC) Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal
More informationPublic health relevant virological features of Influenza A(H7N9) causing human infection in China
Public health relevant virological features of Influenza A(H7N9) causing human infection in China Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional
More informationGUIDE TO REGISTER HOMEOPATHIC PRODUCTS FOR VETERINARY USE
CAMEVET PROCEEDINGS II REVIEW DATE in BRAZIL: HOMEOPATHIC COMMISSION - SINDAN August 18, 2016 GUIDE TO REGISTER HOMEOPATHIC PRODUCTS FOR VETERINARY USE SÃO PAULO, BRAZIL August 2016 Page 2 of 9 GUIDE TO
More informationDefinitions and technical criteria for food ingredients to be considered as natural
TECHNICAL SPECIFICATION ISO/TS 19657 First edition 2017-12 Definitions and technical criteria for food ingredients to be considered as natural Définitions et critères techniques permettant de considérer
More informationIARC Monographs on the Evaluation of Carcinogenic Risks to Humans. VOLUME 93 Carbon Black, Titanium Dioxide, and Talc
WORLD HEALTH ORGANIZATION INTERNATIONAL AGENCY FOR RESEARCH ON CANCER IARC Monographs on the Evaluation of Carcinogenic Risks to Humans VOLUME 93 Carbon Black, Titanium Dioxide, and Talc LYON, FRANCE 2010
More informationTopics covered by the talk
04/02/2016 Finished product monographs containing chemically defined active substances Dr Dirk Leutner Scientific Officer, European Pharmacopoeia Department European Directorate for the Quality of Medicines
More informationISO INTERNATIONAL STANDARD. Oil of spearmint Part 1: Native type (Mentha spicata L.)
INTERNATIONAL STANDARD ISO 3033-1 First edition 2005-09-01 Oil of spearmint Part 1: Native type (Mentha spicata L.) Huile essentielle de menthe crépue (ou menthe verte) Partie 1: Type native (Mentha spicata
More informationISO 8420 INTERNATIONAL STANDARD. Animal and vegetable fats and oils Determination of content of polar compounds
INTERNATIONAL STANDARD ISO 8420 Second edition 2002-04-01 Animal and vegetable fats and oils Determination of content of polar compounds Corps gras d'origines animale et végétale Détermination de la teneur
More informationDRAFT EAST AFRICAN STANDARD
DEAS 44:2016 ICS 67.060 DRAFT EAST AFRICAN STANDARD Milled maize (corn) products Specification EAST AFRICAN COMMUNITY EAS 2016 First Edition 2016 Copyright notice This EAC document is copyright-protected
More informationISO INTERNATIONAL STANDARD. Oil of bitter fennel (Foeniculum vulgare Mill. ssp. vulgare var. vulgare)
INTERNATIONAL STANDARD ISO 17412 First edition 2007-12-01 Oil of bitter fennel (Foeniculum vulgare Mill. ssp. vulgare var. vulgare) Huile essentielle de fenouil amer (Foeniculum vulgare Mill. ssp. vulgare
More informationQuestions & answers on quality of herbal medicinal products/traditional herbal medicinal products 1
12 August 2014 EMA/HMPC/41500/2010 Rev.4 Committee on Herbal Medicinal Products (HMPC) Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products 1 Table of content
More informationThe International Pharmacopoeia - Overview
The International Pharmacopoeia - Overview Caroline Mendy - Technical Officer Quality Assurance and Safety: Medicines World Health Organization 1 The International Pharmacopoeia Ph. Int. Scope WHO Consultative
More informationKENYA STANDARD DKS Moringa leaf products Specification
KENYA STANDARD DKS 2848 Moringa leaf products Specification KEBS 2018 First Edition 2018 TECHNICAL COMMITTEE REPRESENTATION The following organizations were represented on the Technical Committee: Ministry
More informationThank you for your requests under the Freedom of Information Act Please find below responses to your questions.
Our reference: FOI/12-332 Dear Ms Mallinson Thank you for your requests under the Freedom of Information Act 2000. Please find below responses to your questions. 1. Please e-mail copies of the minutes
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 1342 Third edition 2012-10-01 Essential oil of rosemary (Rosmarinus officinalis L.) Huile essentielle de romarin (Rosmarinus officinalis L.) Reference number ISO 1342:2012(E)
More informationWholistic Approach to Herbal Products Quality Case Study: Thyme
Wholistic Approach to Herbal Products Quality Case Study: Thyme Adnan Badwan, Hashim Taha and Nadia Abu Nimeh Delass Natural Products Company, Naor-Jordan The First International Conference on Natural
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 6539 Third edition 2014-02-15 Cinnamon (Cinnamomum zeylanicum Blume) Specification Cannelle (Cinnamomum zeylanicum Blume) Spécifications Reference number ISO 6539:2014(E) ISO
More informationGeneral concepts in the Ph. Eur.: theory and rationale
General concepts in the Ph. Eur.: theory and rationale Cathie VIELLE Head of European Pharmacopoeia Department, EDQM / CoE 1 The structure of the Ph. Eur. General monographs Dosage form monographs General
More informationOverview of USP General Chapters <476> and <1086> Prescription/Non-Prescription Stakeholder Forum October 19, 2017
Overview of USP General Chapters and Prescription/Non-Prescription Stakeholder Forum October 19, 2017 Introduction Periodic review of existing general chapters Typically an approximately 5
More informationCOMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL
European Medicines Agency Evaluation of Medicines for Human Use London, 11 January 2007 Ref: EMEA/HMPC/182352/2005 Rev. 2 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL PROCEDURE FOR THE PREPARATION
More informationPhytochemical and Physico-Chemical Analysis of Siddha Preparation Magizham Pattai Chooranam
International Journal of Research in Pharmacy and Biosciences Volume 1, Issue 2, December 2014, PP 11-15 ISSN 2394-5885 (Print) & ISSN 2394-5893 (Online) Phytochemical and Physico-Chemical Analysis of
More informationISO INTERNATIONAL STANDARD. Non-destructive testing Penetrant testing Part 1: General principles
INTERNATIONAL STANDARD ISO 3452-1 First edition 2008-09-01 Non-destructive testing Penetrant testing Part 1: General principles Essais non destructifs Examen par ressuage Partie 1: Principes généraux Reference
More informationDecision tree for the safety assessment of botanical cosmetic ingredients. Personal Care Products Council CIR Science and Support Committee
Decision tree for the safety assessment of botanical cosmetic ingredients Personal Care Products Council CIR Science and Support Committee Using the Decision Tree Provided as a guidance tool for finished
More informationDraft agreed by HMPC Quality Drafting Group October Adopted by HMPC 12 November 2013
3 December 2013 EMA/HMPC/453258/2013 Committee on Herbal Medicinal Products (HMPC) Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal
More informationISO IDF 177 INTERNATIONAL STANDARD. Dried skimmed milk Determination of vitamin D content using high-performance liquid chromatography
INTERNATIONAL STANDARD ISO 14892 IDF 177 First edition 2002-02-01 Dried skimmed milk Determination of vitamin D content using high-performance liquid chromatography Lait écrémé sec Détermination de la
More information