Pyrrolizidine alkaloid

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Thursday, April 18, 2024
Reproduction, SCOPE, Eating, Pesticide, Convention, Change control, Confusion, Alkaloid, Climate, Fungus, Directive (European Union), Ethylene oxide, Wind, Wood, Glass, European Medicines Agency, HMPS, QDG, Hygiene, Water, Marketing, Fertilizer, Legislation, Manure, Distillation, Risk, Education, Committee, Compost, Draft, Policy, Person, EMA, Seed, Polycyclic aromatic hydrocarbon, Collection, Freezing, GMP, Risk assessment, GACP, Sunlight, Fermentation, Personal protective equipment, Animal, Herbal, Herbicide, Weather, INTRODUCTION, Documentation, Regeneration, Decontamination, EudraLex, Disease, International trade, European Pharmacopoeia, Part, Livestock, Public, Inhalation, Knowledge, Seedling, Factorization of polynomials, Record, Plant, Skin, API, Irrigation, Part Two, Soil, Directive, Pharmacopoeia, Codex, Guideline, Temperature, Attention, Hydrocarbon, Pyrrolizidine alkaloid, Polychlorinated biphenyl, Growth, Rotation, Incineration, Environment, Humidity, Smell, Ventilation, Light, Bird, Mineral, Fumigation, Pyrrolizidine, SOP, Housing, Smoking, Atmosphere, Postharvest, Rain, Liver, QWP, Medicinal plants

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 6/14

      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Thursday, April 18, 2024
Reproduction, SCOPE, Eating, Pesticide, Convention, Change control, Confusion, Alkaloid, Climate, Fungus, Directive (European Union), Ethylene oxide, Wind, Wood, Glass, European Medicines Agency, HMPS, QDG, Hygiene, Water, Marketing, Fertilizer, Legislation, Manure, Distillation, Risk, Education, Committee, Compost, Draft, Policy, Person, EMA, Seed, Polycyclic aromatic hydrocarbon, Collection, Freezing, GMP, Risk assessment, GACP, Sunlight, Fermentation, Personal protective equipment, Animal, Herbal, Herbicide, Weather, INTRODUCTION, Documentation, Regeneration, Decontamination, EudraLex, Disease, International trade, European Pharmacopoeia, Part, Livestock, Public, Inhalation, Knowledge, Seedling, Factorization of polynomials, Record, Plant, Skin, API, Irrigation, Part Two, Soil, Directive, Pharmacopoeia, Codex, Guideline, Temperature, Attention, Hydrocarbon, Pyrrolizidine alkaloid, Polychlorinated biphenyl, Growth, Rotation, Incineration, Environment, Humidity, Smell, Ventilation, Light, Bird, Mineral, Fumigation, Pyrrolizidine, SOP, Housing, Smoking, Atmosphere, Postharvest, Rain, Liver, QWP, Medicinal plants

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 6/14

      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.