Ethylene oxide

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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4.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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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
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347
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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

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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

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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.

NICE Rapid Empowers Creativity with Liquid Silicone for Resin Jewelry Making

Retrieved on:

Monday, March 25, 2024

Life, Ethylene oxide, Steam, FDA, Growth, Creativity, 3D printing

NICE Rapid works exclusively with liquid silicone rubber molding as a premier injection molding firm.

Key Points:

New York, New York--(Newsfile Corp. - March 25, 2024) - NICE Rapid , a leading provider of innovative manufacturing solutions, is excited to announce its commitment to empowering creativity through the use of liquid silicone for resin jewelry making.
With the growing popularity of resin jewelry among artisans and crafters, NICE Rapid aims to provide high-quality liquid silicone molds that enable artists to unleash their creativity and produce stunning, one-of-a-kind pieces.
As a company dedicated to innovation and creativity, NICE Rapid is thrilled to support the vibrant community of resin jewelry makers with liquid silicone rubber molding .
Especially, NICE Rapid has a large selection of liquid silicone moulds designed especially for creating resin jewelry, such as moulds for pendants, rings, earrings, and more.

Cotchett, Pitre & McCarthy Files Lawsuit on Behalf of Residents of Maywood, CA, for Exposure to Cancer Causing Ethylene Oxide

Retrieved on:

Monday, March 18, 2024

Cotchett, Pitre & McCarthy LLP filed a lawsuit on behalf of many longtime residents of Maywood, CA, next to Vernon, an industrial area, for their decades long exposure to cancer caused by carcinogenic Ethylene Oxide being released into the air.

Key Points:

Cotchett, Pitre & McCarthy LLP filed a lawsuit on behalf of many longtime residents of Maywood, CA, next to Vernon, an industrial area, for their decades long exposure to cancer caused by carcinogenic Ethylene Oxide being released into the air.
Ethylene Oxide is used to sterilize medical equipment and spices but, during the process, some of the Ethylene Oxide escapes the facility into the surrounding air.
Ethylene Oxide is odorless and colorless, so nearby Maywood residents never knew it was in the air surrounding their homes.
According to the National Cancer Institute, and other protective health agencies around the world, Ethylene Oxide is associated with breast cancer, stomach cancer, lymphoma, and leukemia.

Dow announces intent to invest in new world-scale carbonate solvents facility in the U.S.

Retrieved on:

Monday, March 25, 2024

EV, Dow, OCED, Longevity, Growth, Education, Economic development, Ethylene oxide, DOW, Carbon, Mobility, State government, DOE, Renewable energy

Dow is collaborating with the U.S. Department of Energy (DOE) Office of Clean Energy Demonstrations (OCED) and was selected for award negotiations to establish a world-scale carbonate solvents production facility for lithium-ion battery production on the U.S. Gulf Coast.

Key Points:

Dow is collaborating with the U.S. Department of Energy (DOE) Office of Clean Energy Demonstrations (OCED) and was selected for award negotiations to establish a world-scale carbonate solvents production facility for lithium-ion battery production on the U.S. Gulf Coast.
The project is supported by agreements with customers, including leading EV original equipment manufacturers and electrolyte manufacturers.
Carbonate solvents are an important component of the electrolyte inside lithium-ion batteries, which help to enhance battery performance and longevity, enabling the advancement and adoption of electric vehicle technology.
Dow will collaborate with new and existing partners in growing diverse suppliers, workforce development and education, economic development, and local and state government to address infrastructure needs.

Sotera Health Reports Fourth-Quarter and Full-Year 2023 Results; Provides 2024 Outlook

Retrieved on:

Tuesday, February 27, 2024

Acquisition, SHC, Health, Growth, Disclosure, Net income, Segment, Conference, GAAP, Ethylene oxide, Webcast, EO, EPS, Bank statement, Face, Depreciation

2023 net revenues increased 4.5% to $1.05 billion, compared to 2022

Key Points:

2023 net revenues increased 4.5% to $1.05 billion, compared to 2022
CLEVELAND, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Sotera Health Company (“Sotera Health” or the “Company”) (Nasdaq: SHC), a leading global provider of mission-critical end-to-end sterilization solutions, lab testing and advisory services for the healthcare industry, today announced financial results for the fourth-quarter and full-year 2023 and its initial 2024 outlook.
For the fourth-quarter 2023, net revenues increased 23.3% to $310 million, compared with $252 million in the same period a year ago.
For full-year 2023, net revenues increased 4.5% to $1.05 billion, compared with $1.00 billion for full-year 2022.
Updates on recent developments in matters relevant to investors can be found on the Investor Relations section of the Sotera Health website at Investor Relations | Sotera Health .

Global Ethylene Industry Production Capacity & Demand Insights & Forecasts Report 2024-2028 Competitive Overview of ExxonMobil, BASF, Mitsubishi, AkzoNobel, Borealis, and Mitsui Chemicals - ResearchAndMarkets.com

Retrieved on:

Friday, March 8, 2024

The "Global Ethylene Market (By Production Capacity & Demand): Insights & Forecast with Potential Impact of COVID-19 (2024-2028)" report has been added to ResearchAndMarkets.com's offering.

Key Points:

The "Global Ethylene Market (By Production Capacity & Demand): Insights & Forecast with Potential Impact of COVID-19 (2024-2028)" report has been added to ResearchAndMarkets.com's offering.
However, the market growth would be challenged by fluctuations in ethylene prices, hazardous effect of ethylene oxide and stringent government regulations.
A few notable trends may include rising production capacity of ethylene dichloride, growing petrochemical industry and increasing demand for bio-based polyethylene.
The global ethylene market is highly focused and concentrated with the production of polyethylene.

Nippon Shokubai’s Newly Developed Material Contributed the Successful Demonstration of Groundbreaking Renewable Seawater Desalination Plant in Hawaii

Retrieved on:

Thursday, February 29, 2024

The RO system is a technology that involves the pressurization of seawater or wastewater over an RO membrane to remove salts (such as NaCl) and impurities.

Key Points:

The RO system is a technology that involves the pressurization of seawater or wastewater over an RO membrane to remove salts (such as NaCl) and impurities.
Nippon Shokubai and Trevi Systems developed the draw solution to be separated from the recovered water using low grade thermal heat (Photo 1).
This developed draw solution was used in the demonstration pilot plant (500m3/day) operated by Trevi Systems on the islands of Hawaii (*2).
About NIPPON SHOKUBAI CO., LTD.: Nippon Shokubai utilizes the unique technology to manufacture chemicals such as ethylene oxide, acrylic acids, catalysts, superabsorbent polymers.

ClorDiSys' Chlorine Dioxide Gas Medical Device Sterilization Noted as One of the "Best of MD&M West"

Retrieved on:

Wednesday, February 21, 2024

Temperature, Multimedia, Suite, MD, FDA, Chlorine, Conference, Sterilization, Ethylene oxide, EPA, Refrigeration, Industrial gas

As part of the conference ClorDiSys Project Manager, Emily Lorcheim, presented, "Ambient Temperature Medical Device Sterilization with Chlorine Dioxide Gas."

Key Points:

As part of the conference ClorDiSys Project Manager, Emily Lorcheim, presented, "Ambient Temperature Medical Device Sterilization with Chlorine Dioxide Gas."
Chlorine dioxide gas sterilization is indeed the closest alternative to ethylene oxide, with significant advancements as well.
Chlorine dioxide gas sterilization is the closest alternative to ethylene oxide, with significant advancements as well.
ClorDiSys developed its technology through Johnson and Johnson, and chlorine dioxide gas has been providing true sterilization of medical devices for over 25 years.

Sotera Health Announces Fourth-Quarter and Full-Year 2023 Earnings Release Date

Retrieved on:

Thursday, February 15, 2024

Oxide, Ethylene oxide, SHC, Webcast

Following the release, management will hold a conference call at 9:00 a.m. Eastern Time to discuss the Company’s operating highlights and financial results.

Key Points:

Following the release, management will hold a conference call at 9:00 a.m. Eastern Time to discuss the Company’s operating highlights and financial results.
A live webcast of the conference call can be accessed at this link or via the Investor Relations section of the Company’s website at Presentation & Events | Sotera Health , along with the accompanying materials.
Updates can be found from time to time on recent developments in matters relevant to investors on the Investor Relations section of the Company’s website at Investor Relations | Sotera Health .
For developments related to Ethylene Oxide, updates can be found at Ethylene Oxide | Sotera Health .