Fertilizer

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.

TradeXBank AG appoints Viviane Gabard as new Chief Risk Officer

Retrieved on: 
Wednesday, April 10, 2024
FINMA, Commodity, Risk management, Growth, Central bank, Risk, Metal, Executive Committee, Head, Senior, Fertilizer, Bank, European Central Bank, Management

TradeXBank AG announces that it has appointed Viviane Gabard as new Chief Risk Officer.

Key Points: 
  • TradeXBank AG announces that it has appointed Viviane Gabard as new Chief Risk Officer.
  • Zurich, 25 March 2024 – TradeXBank AG today announced the appointment of Viviane Gabard as Chief Risk Officer following Hendrik Weber-Grellet’s decision to leave the bank.
  • Viviane Gabard is due to become a member of the Executive Board upon the conclusion of the necessary regulatory approval.
  • Camille Sednaoui, TradeXBank AG's CEO, says: “I’m delighted to announce Viviane’s appointment as our new Chief Risk Officer.

Iraq Britain Business Council Names AAA Holding Group's CEO Amet Selman as Chairman of the Agritech Committee

Retrieved on: 
Wednesday, March 20, 2024
Agriculture, Partnership, Research, News, The Business Council, Artificial intelligence, Fertilizer

It appointed Amet Selman, the Chairman and Chief Executive Officer (CEO) of AAA Holding Group, as the Chairman and thought leader of the Agritech Committee.

Key Points: 
  • It appointed Amet Selman, the Chairman and Chief Executive Officer (CEO) of AAA Holding Group, as the Chairman and thought leader of the Agritech Committee.
  • The formation of the Agritech Committee by IBBC fueled discussions between leading agricultural and fertilizer corporations, including AAA Holdings, to facilitate sustainable development and technological advancement.
  • Amet Selman, as the chairman of the Agritech Committee, is already in discussion with IBBC members to boost the starting phase of the committee's first project.
  • AAA Holding Group, as it's leading the charge in all three spheres, will be valuable in the long run for the Agritech Committee's progress.

China Bluechem's Profit Achieves Record High in 2023, Up 45.0% Year-on-Yearly to RMB 2.382 Billion

Retrieved on: 
Sunday, March 24, 2024
Methanol, Farmer, Growth, RMB, ESG, Research, Sale, Carbon, CO2, ABS, Pollution, Fertilizer, Acrylonitrile, Chemical industry, Urea, DAP

Net profit attributable to owners of the Company grew 45.0% year-on-yearly to RMB 2.382 billion, which was the best performance since the establishment of the Company.

Key Points: 
  • Net profit attributable to owners of the Company grew 45.0% year-on-yearly to RMB 2.382 billion, which was the best performance since the establishment of the Company.
  • The Board has recommended the payment of a final dividend of RMB0.207 per share (tax inclusive) for 2023, hitting record high and representing a payout ratio of 40%.
  • As a result, China BlueChem's brand value has been enhancing continuously and reached RMB5.404 billion in 2023, up by RMB1.433 billion as compared with the previous year, which was a record-high increment.
  • Furthermore, the Company will intensify research on the resource utilization of carbon-rich natural gas and CO2 to champion carbon reduction.

Brazil Potash Receives Mine Installation License to Start Project Construction of the Autazes Potash Project in Brazil

Retrieved on: 
Tuesday, April 9, 2024
Mining, Farmer, Amazon, Poultry, Risk, Soybean, Indigenous, Plant, License, Fertilizer, Government

MANAUS, Brazil, April 09, 2024 (GLOBE NEWSWIRE) -- Brazil Potash Corp. (“Brazil Potash” or the “Company”) is excited to announce the Amazon State Environmental Protection Institute (IPAAM), has granted the mine Installation License for the Autazes Potash Project (the “Project”) to the 100% owned Brazilian subsidiary Potassio do Brasil, allowing for construction to commence.

Key Points: 
  • MANAUS, Brazil, April 09, 2024 (GLOBE NEWSWIRE) -- Brazil Potash Corp. (“Brazil Potash” or the “Company”) is excited to announce the Amazon State Environmental Protection Institute (IPAAM), has granted the mine Installation License for the Autazes Potash Project (the “Project”) to the 100% owned Brazilian subsidiary Potassio do Brasil, allowing for construction to commence.
  • The Company expects to start construction with the awarding of contracts for mine surface works and shaft construction.
  • Now, with the License approval, Brazil can produce this essential mineral for its farmers in country, by-passing the risk and costs of imports.
  • Potash is extremely important to efficiently grow food as it strengthens the stem of plants to make them more resilient to stresses caused by drought, extreme temperatures, and insect infestation.

FuelPositive Welcomes Deputy Minister of Agriculture and Agri-Food Canada to Facility in Waterloo and Announces Non-Brokered Private Placement

Retrieved on: 
Thursday, April 4, 2024
Sustainability, Climate change, Government, Farmer, TSX Venture Exchange, Debt, Offering, University, Biophysical environment, GHG, Chairperson, Research, Mental health, Policy, Anxiety, Ontario Agricultural College, Rural development, Quality of life, Central Statistics Office (India), EEStor, RPP, Fertilizer, Suicide, MCIP, Animal, Federal, School, Agriculture

"Deputy Minister Beck recently visited our team at our new facility during her visit to the Kitchener-Waterloo region.

Key Points: 
  • "Deputy Minister Beck recently visited our team at our new facility during her visit to the Kitchener-Waterloo region.
  • Deputy Minister Beck was joined by Alec Nicholls, Director General, Agriculture and Agri-Food Canada, Melissa Reginato, Senior Markets and Trade, Agriculture and Agri-Food Canada and Hadley Carpenter, Regional Director, Agriculture and Agri-Food Canada, who was instrumental in organizing the visit.
  • Our technology embodies the spirit of progress and collaboration and showcases Canada's leadership in pioneering solutions that address pressing global challenges.
  • The governmental visit was a valuable opportunity for the FuelPositive team to engage in meaningful discussions with Deputy Minister Beck.

Itronics Positioned to Benefit From Historic High and Rising Gold Prices

Retrieved on: 
Thursday, April 4, 2024
Tin, Silver, Transport, Zinc, Gold, Clean technology, Metal, Copper, Lead, Geology, United, Mineral, Research and development, Mining, OTC, Intellectual property, Probability, ITRO, Economics, Fertilizer, Iron

Gold, silver, and other precious metals have made a sustained push toward historically high prices over the last several months.

Key Points: 
  • Gold, silver, and other precious metals have made a sustained push toward historically high prices over the last several months.
  • Itronics is currently engaged in three significant technology areas enhancing non-cyanide gold recovery, alongside a technique to improve cyanide-based heap leach gold recovery processes.
  • This is an Itronics technology advantage that provides a measurable economic benefit and increases the significance of rising gold and silver prices.
  • “By leveraging its ability to maximize the recovery of value from metals resources, Itronics, its clients, and its investors stand to benefit greatly by the historic rise in gold prices,” said Itronics President Dr. John Whitney.

Verde Announces Q4 and FY 2023 Results

Retrieved on: 
Thursday, March 28, 2024
Potassium chloride, Farmer, Central bank, FY, CNM, Risk, Global warming potential, History, ECLS, Carbon, Carbon dioxide, Fertilizer, Depreciation, Weather

SINGAPORE, March 28, 2024 (GLOBE NEWSWIRE) -- Verde AgriTech Ltd (TSX: “NPK”) ("Verde” or the “Company”) announces its financial results for the full year ended December 31, 2023 (“FY 2023”) and the fourth quarter 2023 (“Q4 2023”), as audited by Ernst & Young (“EY”). The FY 2023 audited results were consistent with the interim results announced by the Company on January 26, 2024:

Key Points: 
  • Verde's revenue amounted to $37.9 million in FY 2023, a 53% decrease compared to the previous year, when potash prices reached record levels.
  • The Company reported a net loss of $6.0 million in FY 2023, compared to a net profit of $17.8 million in FY 2022.
  • Canadian dollar devaluated by 7% versus Brazilian Real in FY 2023 compared to FY 2022.
  • The Company will host a conference call on Tuesday, April 02, 2024, at 10:00 am Eastern Time, to discuss Q4 and FY 2023 results and provide an update.

Rumo and DP World Announce Agreement to Develop a New Grain and Fertilizer Terminal at Brazil’s Port of Santos

Retrieved on: 
Tuesday, March 26, 2024
DP, DP World, Agriculture, Partnership, Länderbahnen, Cellulose, USD, Port, Fertilizer

SANTOS, BRAZIL, March 26, 2024 (GLOBE NEWSWIRE) -- Rumo, Brazil’s leading railway operator, and DP World , a global leader in supply chain solutions, have signed an agreement to build a new port terminal for grains and fertilizers at the Port of Santos, Brazil.

Key Points: 
  • SANTOS, BRAZIL, March 26, 2024 (GLOBE NEWSWIRE) -- Rumo, Brazil’s leading railway operator, and DP World , a global leader in supply chain solutions, have signed an agreement to build a new port terminal for grains and fertilizers at the Port of Santos, Brazil.
  • The project will be installed in DP World's private-use terminal on the port’s left bank.
  • The agreement provides for an initial operating period of 30 years, with an option for extension subject to DP World approval.
  • DP World will oversee the ensuing port operations, including cargo movement, solidifying its position as Brazil’s premier multipurpose port operator.