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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
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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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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
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?

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317

?

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320

?

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322

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323
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325

?

326
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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.

SOPERIOR FERTILIZER PREPARING OBA SUBMISSION

Retrieved on:

Friday, March 22, 2024

FEED, TSX Venture Exchange, NEX, JV, OBA, SOP, School

Toronto, ON, Canada, March 22, 2024 (GLOBE NEWSWIRE) -- SOPerior Fertilizer Corp. (the “Company” or “SOP”) (NEX:SOP.H).

Key Points:

Toronto, ON, Canada, March 22, 2024 (GLOBE NEWSWIRE) -- SOPerior Fertilizer Corp. (the “Company” or “SOP”) (NEX:SOP.H).
The Company informs that its existing 10-year Other Business Arrangement (“OBA”) with the School and Institutional Trust Lands Administration (“SITLA”) for the Blawn Mountain mineral leases expires on April 1, 2024.
SOP is engaged with the regulator and working on its submission for a renewed OBA.
Depending on the duration of the SITLA review process, it is expected that the OBA will be tabled for approval at one of those two meetings.

Zebra Technologies to Unveil New Generative AI Capabilities at Google Cloud Next

Retrieved on:

Thursday, April 4, 2024

Zebra Technologies Corporation (NASDAQ: ZBRA), a leading digital solution provider enabling businesses to intelligently connect data, assets, and people today announced its collaboration with Google Cloud, Android, and Qualcomm Technologies, Inc. to help enterprises deliver transformative customer experiences along with improved employee productivity and insights powered by generative AI.

Key Points:

Zebra Technologies Corporation (NASDAQ: ZBRA), a leading digital solution provider enabling businesses to intelligently connect data, assets, and people today announced its collaboration with Google Cloud, Android, and Qualcomm Technologies, Inc. to help enterprises deliver transformative customer experiences along with improved employee productivity and insights powered by generative AI.
These new, innovative capabilities will be previewed next week at the 2024 Google Cloud Next in Las Vegas.
“Generative AI is fundamentally changing how many organizations operate and will fuel a new era of how both customers and employees will interact with businesses and brands,” said Rouzbeh Aminpour, Global Retail Solution Engineering Manager, Google Cloud.
“By utilizing Google Cloud’s leading gen AI capabilities, Zebra can help companies across industries empower their employees with better tools and new capabilities, making their work more productive.”
Bianculli will be joined by Aminpour and other leaders from Google Cloud and SAP to discuss how enterprises can reimagine document processing and understanding with generative AI during a breakout session at the Google Cloud Next event on April 11, 10:15-11am PDT.

Semiconductor & IC packaging materials Market worth $70.9 billion by 2029 - Exclusive Report by MarketsandMarkets™

Retrieved on:

Monday, March 25, 2024

Polychlorinated biphenyl, Growth, Kyocera, IC, Amkor Technology, Internet of things, LG Chem, Tablet, Electronics, AI, Texas Instruments, SOP, SMT, PCB, Ceramic

They also offer robust protection against environmental factors like moisture and mechanical stress, ensuring the durability and reliability of semiconductor devices.

Key Points:

They also offer robust protection against environmental factors like moisture and mechanical stress, ensuring the durability and reliability of semiconductor devices.
In essence, the amalgamation of compactness, high pin density, SMT compatibility, thermal management capabilities, versatility, and excellent electrical performance positions SOP technology as the preferred choice in the semiconductor and IC packaging materials market.
Additionally, rapid innovation in technologies such as AI, AR, and IoT requires packaging materials supporting high-speed data processing and thermal management.
This sector heavily relies on semiconductor and IC packaging materials for a wide array of products including smartphones, laptops, wearables, and automotive electronics.

Semiconductor & IC packaging materials Market worth $70.9 billion by 2029 - Exclusive Report by MarketsandMarkets™

Retrieved on:

Monday, March 25, 2024

Polychlorinated biphenyl, Growth, Kyocera, IC, Amkor Technology, Internet of things, LG Chem, Tablet, Electronics, AI, Texas Instruments, SOP, SMT, PCB, Ceramic

They also offer robust protection against environmental factors like moisture and mechanical stress, ensuring the durability and reliability of semiconductor devices.

Key Points:

They also offer robust protection against environmental factors like moisture and mechanical stress, ensuring the durability and reliability of semiconductor devices.
In essence, the amalgamation of compactness, high pin density, SMT compatibility, thermal management capabilities, versatility, and excellent electrical performance positions SOP technology as the preferred choice in the semiconductor and IC packaging materials market.
Additionally, rapid innovation in technologies such as AI, AR, and IoT requires packaging materials supporting high-speed data processing and thermal management.
This sector heavily relies on semiconductor and IC packaging materials for a wide array of products including smartphones, laptops, wearables, and automotive electronics.

HYZON ANNOUNCES FOURTH QUARTER 2023 FINANCIAL AND OPERATING RESULTS

Retrieved on:

Friday, March 22, 2024

Membrane electrode assembly, Burn, Q&A, Food group, REMONDIS, Sale, Public expenditure, SOP, FCEV, Volvo, Investment, PFG, Performance Food Group, FCS, Gesellschaft mit beschränkter Haftung, Propane

BOLINGBROOK, Ill., March 22, 2024 /PRNewswire/ -- Hyzon (NASDAQ: HYZN) (Hyzon or the Company), a U.S.-based manufacturer and global supplier of high-performance hydrogen fuel cell systems focused on providing zero-emission power to decarbonize the most demanding industries, today announced its fourth quarter 2023 financial and operational results:

Key Points:

As of December 31, 2023, Hyzon deployed 19 vehicles under commercial agreements to customers in 2023, towards the upper end of its annual guidance range of 15-20 vehicles.
Hyzon also delivered four FCEVs to leading food distributor and supplier, PFG, in December 2023.
Hyzon completed its B-sample development phase of the 200kW Fuel Cell System (FCS) in Q4 2023, and advanced to C-sample development phase.
The Hyzon management team will host a conference call to discuss its fourth quarter financial results on Friday, March 22, 2024 at 8:30 am Eastern Time.

Hesai Group Reports Fourth Quarter and Full Year 2023 Unaudited Financial Results

Retrieved on:

Monday, March 11, 2024

EV, OEM, USD, Transport, Growth, Original equipment manufacturer, NOA, Great Wall Motor, Defense, MEGA, Stellantis, Chinese New Year, CES, SOP, Accident, Robotics, Beauty salon

SHANGHAI, China, March 11, 2024 (GLOBE NEWSWIRE) -- Hesai Group (“Hesai” or the “Company”), (NASDAQ: HSAI), the global leader in three-dimensional light detection and ranging (lidar) solutions, today announced its unaudited financial results for the three months and full year ended December 31, 2023.

Key Points:

Q4 2023 Total lidar shipments were 87,736 units, representing an increase of 84.6% from 47,515 units in the corresponding period of 2022.
“2023 was another record year for Hesai as we continued to substantially outperform our lidar peers and extend our leading market share.
We delivered stellar full-year financial and operational results, including robust revenue growth, soaring shipments and solid blended gross margin, all surpassing our prior expectations.
We expect the third and fourth quarters orders to jump even further to about 200,000 units per quarter, a 4x increase from our expected first quarter shipments.

American Lithium Files Robust PEA for Falchani Hard Rock Lithium Project with Highlights Including a Tripling of After-tax NPV8 to US$5.11 Billion

Retrieved on:

Monday, February 26, 2024

“This is a major milestone in the process to complete pre-feasibility and move the Project into mine permitting.

Key Points:

“This is a major milestone in the process to complete pre-feasibility and move the Project into mine permitting.
The filing of the Semi-Detailed Environmental Impact Assessment late last year also positions the Project to be fast-tracked.
American Lithium is actively engaged in the development of large-scale lithium projects within mining-friendly jurisdictions throughout the Americas.
American Lithium was subsequently notified that INGEMMET and MINEM have filed petitions to the Supreme Court of Peru to assume jurisdiction in the proceedings.

Agrify Corporation Announces First Multi-Year and Two-Million Dollar Extraction Managed Services Contract with Customer in Michigan

Retrieved on:

Thursday, February 22, 2024

Diamond, EVP, HDU, Partnership, Service provider, Managed services, SOP, PDS, Palladium

Agrify’s Managed Services is a first-of-its-kind program where Agrify leases turnkey extraction and post-processing lab equipment to qualified operators and provides a full-time customer success specialist to guide and manage extraction-related operations for the customer.

Key Points:

Agrify’s Managed Services is a first-of-its-kind program where Agrify leases turnkey extraction and post-processing lab equipment to qualified operators and provides a full-time customer success specialist to guide and manage extraction-related operations for the customer.
Managed Services allows Agrify to significantly increase the average lifetime value of our customers.
Agrify could potentially earn up to $2 million throughout the lifetime of this multi-year managed service contract with PDS Ventures.
“We are extremely excited to launch our end-to-end managed service contract with PDS Ventures,” said Brian Towns, EVP & General Manager of Agrify.