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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
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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

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271
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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
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313

?

314
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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

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.

Hydroponics Equipment Global Market Report 2024 - Modified Norway Spruce Wood Fiber Grow Medium Enhances Hydroponic Strawberry Production - ResearchAndMarkets.com

Retrieved on:

Monday, March 18, 2024

Cannabis, Other Natural Resources, HVAC, Hemp, Manufacturing, Agriculture, Natural Resources, Hydroponics, Control system, Irrigation, Heat

The "Hydroponics Equipment - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering.

Key Points:

The "Hydroponics Equipment - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering.
This report reviews, analyzes and projects the global Hydroponics Equipment market for the period 2020-2029 in terms of market value in US$ and the compound annual growth rates (CAGRs) projected from 2023 through 2029.
Hydroponics equipment is primarily needed for indoor farming and comprises Heating, Ventilation, & Air Conditioning (HVAC) Systems, LED Grow Lights, Irrigation Systems, Control Systems and Material Handling Equipment.
The overall global market for Hydroponics Equipment is expected to surpass US$5 billion in 2024.

Electricity Empowers "Red Cherry" and Safeguard Rural Vitalization

Retrieved on:

Monday, March 18, 2024

Electricity, Irrigation, Temperature, Sound, Farmer, Growth, Agriculture, Knowledge, Yanya, Shandong, Tree, Government, Renewable energy

ZIBO, China, March 18, 2024 /PRNewswire/ -- "We should express our gratitude to you for your service as we don't need to worry about the electricity supply of our cherry greenhouses anymore."

Key Points:

ZIBO, China, March 18, 2024 /PRNewswire/ -- "We should express our gratitude to you for your service as we don't need to worry about the electricity supply of our cherry greenhouses anymore."
Adhere to the idea of serving the people, Yiyuan Power Supply Company (managed by State Grid Zibo Power Supply Company) put prevention first in service to actively connect with key projects of rural vitalization in government and enterprises, closely monitor the growth trend of electricity load and deeply conduct the overhaul of agricultural irrigation equipment and maintenance of characteristic industries.
Electricity is the prerequisite of rural vitalization.
Stable electricity supply together with premium and considerable electricity service ensure the healthy development of cherry industry in Yiyuan and boost persistent "overheating" of characteristic industries in rural area and modern agriculture, which delivers invaluable assets to Yiyuan on the basis of its lucid waters and lush mountains.

The Future of Design Is Here with AI in Vectorworks 2024 Update 4

Retrieved on:

Wednesday, March 13, 2024

Cloud, Odyssey, Cabinet, Style, Documentation, Apple, VR, Hardscape, Meta Quest 2, Virtual reality, BIM Collaboration Format, Spotlight, Partnership, Mac, Meta, Freedom, 3D, AI, Plant, Update, Workflow, Help, Stable Diffusion, IDS, BCF, Landscape, Creativity, L-Acoustics, Irrigation, BIM, IOS, Redshift, Conversion, Video game

COLUMBIA, Md., March 13, 2024 /PRNewswire/ -- Global design and BIM software provider Vectorworks, Inc., part of the Nemetschek Group, has released its fourth update to the Vectorworks 2024 product line, granting customers access to AI and virtual reality (VR) technologies through two brand new tools. Additionally, the latest version update features an integration with L-Acoustics – leaders in sound-reinforcement technology and the Vectorworks Partner Network's first platinum audio industry member – along with several other enhancements to provide faster design workflows from start to finish.

Key Points:

Latest Vectorworks Update Introduces New Capabilities in AI Visualization, Virtual Reality, BIM Collaboration, and More to Deliver Added Design Freedom and Flexibility.
Combining the power of Vectorworks with the speed of AI powered by Stable Diffusion, customers have the limitless potential of AI at their fingertips with the new AI Visualizer.
Vectorworks' AI Visualizer is processed on Vectorworks Cloud Services, ensuring that individual hardware limitations do not impact performance.
Unleash your creative potential and unlock limitless design possibilities with a free 7-day trial of Vectorworks Design Suite .

The Future of Design Is Here with AI in Vectorworks 2024 Update 4

Retrieved on:

Wednesday, March 13, 2024

COLUMBIA, Md., March 13, 2024 /PRNewswire/ -- Global design and BIM software provider Vectorworks, Inc., part of the Nemetschek Group, has released its fourth update to the Vectorworks 2024 product line, granting customers access to AI and virtual reality (VR) technologies through two brand new tools. Additionally, the latest version update features an integration with L-Acoustics – leaders in sound-reinforcement technology and the Vectorworks Partner Network's first platinum audio industry member – along with several other enhancements to provide faster design workflows from start to finish.

Key Points:

Latest Vectorworks Update Introduces New Capabilities in AI Visualization, Virtual Reality, BIM Collaboration, and More to Deliver Added Design Freedom and Flexibility.
Combining the power of Vectorworks with the speed of AI powered by Stable Diffusion, customers have the limitless potential of AI at their fingertips with the new AI Visualizer.
Vectorworks' AI Visualizer is processed on Vectorworks Cloud Services, ensuring that individual hardware limitations do not impact performance.
Unleash your creative potential and unlock limitless design possibilities with a free 7-day trial of Vectorworks Design Suite .

Landscapers, Contractors & Dealers Ready for Bright Futures, Powered by Equip Expo Education

Retrieved on:

Tuesday, March 12, 2024

Loch Ness, Equip, Irrigation Association, Expo, The Morning Show, Equipment, Irrigation, OPEI, Human, Marketing

LOUISVILLE, Ky., March 12, 2024 /PRNewswire/ -- Landscapers, contractors and outdoor power equipment dealers can develop their skills and take advantage of new trends impacting their industry thanks to expanded education and certification classes at Equip Exposition this October 15-18 at the Kentucky Exposition Center (KEC).

Key Points:

Landscaper-led events are back at Equip and continue to offer landscapers a platform to connect and grow together.
Both events are included with your Equip registration.
"If you're looking to grow your business, this is the place to be," sums up Mandy Muschler of Lochness LLC.
Ami Neiberger, Four Leaf PR on behalf of OPEI, 703-887-4877, [email protected]
Debbi Mayster, Four Leaf PR on behalf of OPEI, 240-988-6243, [email protected]

Water Recycle and Reuse Market Trends Report 2024-2032, Featuring Alfa Laval, Aquatech, DeLoach Industries, Ecolab, Evoqua Water Technologies, Lenntech and Veolia Environnement

Retrieved on:

Friday, March 8, 2024

Weather, Investment, Government, Commercial, Climate change, Irrigation, Industrial, Non-governmental organization, Recycling, Conventional treatment, Human, Water, Agriculture

As a result, water recycle and reuse are used to reduce pollution discharges and ensure water sustainability and security.

Key Points:

As a result, water recycle and reuse are used to reduce pollution discharges and ensure water sustainability and security.
The report has also provided a detailed breakup and analysis of water recycle and reuse market based on the technology.
A detailed breakup and analysis of the water recycle and reuse market based on the end user has also been provided in the report.
Who are the key players/companies in the global water recycle and reuse market?

The SoCal Laborers Training School Graduates More Than 750 Highly-Skilled Construction Professionals To Journeyperson Status

Retrieved on:

Wednesday, February 14, 2024

View the full release here: https://www.businesswire.com/news/home/20240214780580/en/

Key Points:

View the full release here: https://www.businesswire.com/news/home/20240214780580/en/
Business Manager of the Southern California District Council of Laborers Jon P. Preciado addresses the 2023 graduates and their families.
(Photo: Business Wire)
“The graduates’ years of grit, sacrifice and perseverance show the commitment that our members and this union have for the construction industry.
Presently, the Laborers’ Training School has nearly 2,500 indentured apprentices employed full-time for one of LIUNA’s over 2,000 union-signatory contractors in Southern California.
The Laborers’ School operates 12 facilities in Southern California and provided more than 387,361 hours of construction skills training in 2023.

Netherlands Agriculture Equipment Market Embarks on a High-Tech Growth Path

Retrieved on:

Tuesday, February 6, 2024

Agriculture, Crop, Cultivator, Harvest, Tractor, Irrigation, Harvester, Farmer, Urbanization, Farm, Land development, Equipment

Italy Agriculture Equipment Market Outlook to 2027 Unleashing Innovation and Growth: Exploring Italy Thriving Agriculture Equipment Market

Key Points:

Italy Agriculture Equipment Market Outlook to 2027 Unleashing Innovation and Growth: Exploring Italy Thriving Agriculture Equipment Market
The market will grow at a CAGR of 13.3% during 2022-2027 due to increase of mechanized farming & supportive government policies.
Mechanized farming allows higher levels of efficiency and precision in various agricultural tasks, leading to increased productivity.
Modern machinery, like advanced tractors, harvesters, and planting equipment, can perform tasks more quickly and accurately than traditional manual methods.
Indonesia Agriculture Equipment Market Outlook to 2025 By Tractors Market (2 Wheeled & 4 Wheeled Tractors; 70HP Tractors; Combine Harvesters Market (Less than 70HP, 70HP and >70HP); Rice Transplanters Market; Implements Market (Rotavator, Plough, Harrow, Fertilizer Spreaders & Others)
The mechanization rate for land preparation is higher in Indonesia and it is forecasted to get mechanized further as the farmers are likely to increase the usage of disc plow on the farms.