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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

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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

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104

4.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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149

8.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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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
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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
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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

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?

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.

EQS-News: Negative market environment strongly impacts 2023 earnings – implementation of performance program exceeds plan

Retrieved on:

Wednesday, April 10, 2024

CDP, Organization, CAPEX, Growth, Environment, Lenzing AG, Clothing, EU Ecolabel, IMF, Hygiene, Depreciation, Marketing, Cryptocurrency

The largely absent recovery in the textile and clothing industry had a negative impact across the entire sector.

Key Points:

The largely absent recovery in the textile and clothing industry had a negative impact across the entire sector.
Prices for wood-based specialty fibers were also down slightly due to weaker demand, particularly from brands and retailers, as well as additional market capacity.
Earnings before interest, tax, depreciation and amortization (EBITDA) rose by 25.4 percent year-on-year to reach EUR 303.3 mn in the reporting year.
Earnings after tax amounted to minus EUR 593 mn (compared with minus EUR 37.2 mn in 2022) and earnings per share to minus EUR 20.02 (compared with minus EUR 2.75 in 2022).

Five Talented Women Scientists from the Global South Win OWSD-Elsevier Foundation Research Prize for Their Work on New Ways to Tackle Water Quality Issue

Retrieved on:

Thursday, March 21, 2024

The 2024 OWSD-Elsevier Foundation Awards have recognized women-led science from more than 20 low- and middle-income countries since 2013

Key Points:

The prize also acknowledges the scientists’ commitment to leadership, mentoring and engagement within their communities, including the translation of research into actionable insights for stakeholders.
We are so proud of them and are sure this prize is just one step on their path to success."
By offering this prize, we want to spotlight the important research undertaken by the women who've become inspiring role models for communities most affected by this issue."
To find out how the OWSD-Elsevier Foundation Award helps shape our understanding of the global South, read more about the 2023 winners here .

APEL Biomedical Technology Innovation and Translational Commercial Laboratory Officially Opens

Retrieved on:

Wednesday, March 13, 2024

Dr. Grace Lau, Head of Institute for Translational Research of Hong Kong Science and Technology Parks Corporation (HKSTP) stated, "It is great to see the official opening of APEL Laboratory and the successful transformation of scientific research and technology into commercial products.

Key Points:

Dr. Grace Lau, Head of Institute for Translational Research of Hong Kong Science and Technology Parks Corporation (HKSTP) stated, "It is great to see the official opening of APEL Laboratory and the successful transformation of scientific research and technology into commercial products.
We have attracted numerous biomedical innovation and technology enterprises, covering areas such as pharmaceuticals, medical devices, diagnostics, and traditional Chinese medicine.
Today, we are delighted to have officially established our presence in Hong Kong Science Park with the opening of the Biomedical Technology Innovation and Translational Commercial Laboratory.
The pet industry ecosystem is vibrant, and today, during the inauguration ceremony of the APEL Biomedical Technology Innovation and Translational Commercial Laboratory, APEL also organized a panel discussion on the future opportunities and transformations in the pet industry.

Jason Scott Joins Sectigo as Chief Information Security Officer

Retrieved on:

Tuesday, April 9, 2024

Software, Technology, Internet, Security, Comodo Cybersecurity, Hygiene, CLM, Government, Army

Jason will oversee all aspects of cybersecurity at Sectigo including data, infrastructure, network, applications, and products.

Key Points:

Jason will oversee all aspects of cybersecurity at Sectigo including data, infrastructure, network, applications, and products.
“It’s exciting to join a company that is expanding into new markets and growing as quickly as Sectigo is,” said Jason.
“The company’s mission to deliver the simplest, most secure, and most scalable CLM solutions make cyber hygiene and a strong security posture critical to success.
“We are pleased to welcome Jason to the Sectigo family,” said Sectigo Chief Product and Engineering Officer Mark Bilger .

Excel Dryer pioneers blueprint for healthy and sustainable workplaces of the future

Retrieved on:

Tuesday, April 9, 2024

Health, Certification, Hand, Beauty, WELL, Life, Excel Dryer, CEU, Curriculum, Hand dryer, Architectural Record, Hygiene, Microsoft Excel, LEED, Workplace, Movement, Management

EAST LONGMEADOW, Mass., April 9, 2024 /PRNewswire/ -- Excel Dryer, the global leader in touchless hand hygiene solutions, recently unveiled a comprehensive office expansion and renovation project. This initiative, rooted in the company's mission to lead through innovation, aimed to merge beauty, health, wellness and sustainability into its workplace. The project's insights and methodologies are set to educate through a unique continuing education unit (CEU) course, offered by Architectural Record magazine in its Continuing Education Center, serving as a detailed roadmap of Excel Dryer's innovative journey.

Key Points:

EAST LONGMEADOW, Mass., April 9, 2024 /PRNewswire/ -- Excel Dryer , the global leader in touchless hand hygiene solutions, recently unveiled a comprehensive office expansion and renovation project.
This initiative, rooted in the company's mission to lead through innovation, aimed to merge beauty, health, wellness and sustainability into its workplace.
William Gagnon, COO of Excel Dryer, said, "Our vision was clear from the start—to craft the most beautiful, healthy and sustainable workplace imaginable.
Ultimately, the course showcases how integrated design solutions can promote health, efficiency and environmental stewardship in commercial spaces.

Drainage Solutions to Enhance Product Safety for the F&B and Pharma Industries, Upcoming Webinar Hosted by Xtalks

Retrieved on:

Tuesday, April 9, 2024

ACO, F&B, Drainage, Food, Hygiene, Tissue paper

TORONTO, April 9, 2024 /PRNewswire-PRWeb/ -- Maintaining hygienic processes is vital for the continuity and success of operations in sectors such as food and beverage (F&B) and pharmaceuticals. Ensuring stringent hygiene standards helps prevent contamination risks, including the proliferation of harmful bacteria like Listeria, which is critical for product safety and managing cleaning costs.

Key Points:

The featured speaker will discuss the benefits of hygienic drainage solutions.
This webinar focuses on the importance of hygienic drainage solutions in maintaining optimal hygiene within facilities.
Register for this webinar today to gain insights into best practices and innovations in drainage solutions that contribute to safer and more efficient operations.
Join Leonel Leal, Sales & Product Development Manager, ACO Building Drainage , for the live webinar on Thursday, April 25, 2024, at 1pm EDT (10am PDT).

Global Disposable Gloves Market Outlook & Forecast 2024-2029, Featuring Key Vendors Ansell, Hartalega Holdings, Kossan Rubber Industries, Rubberex, Supermax, Top Glove and UG Healthcare - ResearchAndMarkets.com

Retrieved on:

Monday, April 1, 2024

The global disposable gloves market is characterized by dynamic and competitive forces shaped by supply and demand factors.

Key Points:

The global disposable gloves market is characterized by dynamic and competitive forces shaped by supply and demand factors.
Prominent manufacturers include Ansell, Hartalega Holdings, Kossan Rubber Industries, Rubberex, Supermax, Top Glove, and UG Healthcare.
The global disposable gloves market, mainly fueled by the rising demand for nitrile gloves, stands at a pivotal juncture.
Disposable gloves have become indispensable in healthcare, food processing, manufacturing, and other sectors, shaping a robust market landscape in the region.

Global Garden Hand Tools Market Outlook & Forecast 2024-2029: Emergence of DIY Gardening Culture and Soaring Popularity of Vertical Gardening Droves Hand Tools Market Growth - ResearchAndMarkets.com

Retrieved on:

Monday, April 1, 2024

As a result, there will likely be an increase in the need for ergonomic garden hand tools for garden establishment and maintenance.

Key Points:

As a result, there will likely be an increase in the need for ergonomic garden hand tools for garden establishment and maintenance.
Also, a key factor driving the expansion of the garden hand tools market is the rise in native gardening techniques.
The online distribution channel segment holds the most prominent share in the global garden hand tools market.
APAC dominated the global garden hand tools market, valued at over USD 6.74 billion in 2023.