Part Two | Jotup

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

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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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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
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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
310

?

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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

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.

Award-Winning Actress & Performer Hannah Waddingham to Serve as Godmother of Stunning Sun Princess

Retrieved on:

Monday, April 8, 2024

FT. LAUDERDALE, Fla., April 8, 2024 /PRNewswire/ -- Award-winning actress and performer Hannah Waddingham will serve the time-honored, maritime tradition as the official Godmother of Princess Cruises' newest "Love Boat" Sun Princess. The star-studded naming ceremony will take place at the Port of Barcelona on April 23, 2024.

Key Points:

Waddingham joins an esteemed group who have served as Godparent to Princess ships: Diana, Princess of Wales (Royal Princess, 1984), Kate Middleton, Princess of Wales (Royal Princess, 2013); Audrey Hepburn (Star Princess, 1989); Sophia Loren (Crown Princess, 1990); Martha Stewart (Crown Princess, 2006), among many notable celebrities.
Earlier this year, Waddingham earned a BAFTA TV Award nomination for her own Apple TV+ holiday special "Hannah Waddingham: Home for Christmas."
"We're delighted to welcome the illuminous and elegant Hannah Waddingham to serve as Godmother for our sensational new Sun Princess," said John Padgett, Princess Cruises president.
"Just like Sun Princess, she exudes sophistication, beauty and wonderment through her inspiring work as a talented and award-winning actress and performer.

Tyton Partners Choose to Learn 2024 Part 2 Dives into the Journey of the K-12 Parents who are Moving Out of Public School, from Awareness to Enrollment

Retrieved on:

Wednesday, March 13, 2024

Navigator, Organization, Barrier, Learning, Part, Education, Research, Child, Love, Parent, Part Two, Toy

This 2024 Choose to Learn initiative assesses the breadth of preferences from 2,000+ parents for alternative education pathways beyond public school and the barriers these parents face.

Key Points:

This 2024 Choose to Learn initiative assesses the breadth of preferences from 2,000+ parents for alternative education pathways beyond public school and the barriers these parents face.
Continuing the efforts from Choose to Learn 2024 Part 1, which highlighted the 48% of “Open-minded” parents who are seeking new educational programs, Part 2 assesses the journey of these parents from awareness to enrollment.
Key findings from Choose to Learn 2024 Part 2 include:
Two main barriers hinder K-12 parents from completing the journey to a new educational option: affordability and awareness of program options.
A program that (re)ignites a child’s love for learning is what drives K-12 parents to choose a new education program.

Velatura Announces Revolutionary Pilot Project with DocuSign to Streamline Patient Consent, Improve Efficiency

Retrieved on:

Monday, March 11, 2024

Mental health, DocuSign, HDU, Empowerment, PHI, CFR, MHA, HIPAA, Part Two, Patient, HIE, Privacy, Michigan State University, QR, Partnership, Nursing

Secure and timely sharing of patient information between patients and providers is crucial for delivering coordinated care across diagnoses, treatments and healthcare settings.

Key Points:

Secure and timely sharing of patient information between patients and providers is crucial for delivering coordinated care across diagnoses, treatments and healthcare settings.
“By joining forces with Velatura, we’re not only streamlining patient consent – we’re revolutionizing it,” said Robert Chatwani, President & General Manager of Growth at DocuSign.
Together, we are leveraging technology to streamline workflows and fundamentally reshape healthcare for the better.”
The pilot project will begin rolling out to select Velatura network provider facilities this spring.
Velatura and DocuSign will be hosting a webinar titled, “Beyond Paperwork: Optimizing Patient Consent for Improved Healthcare Coordination,” with a panel discussion on March 19 at 1 p.m. ET/10 a.m. PT.

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on:

Monday, March 11, 2024

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points:

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Constellation Forecasts Strong Earnings Growth in 2024 and Beyond as Demand and Support for Clean Energy Builds

Retrieved on:

Tuesday, February 27, 2024

“State and federal policies, bipartisan political support, public opinion surveys and increased customer demand for reliable and clean energy all point to strong and growing support for nuclear energy to power our economy for decades to come.

Key Points:

“State and federal policies, bipartisan political support, public opinion surveys and increased customer demand for reliable and clean energy all point to strong and growing support for nuclear energy to power our economy for decades to come.
The PTC provides revenue visibility and also preserves Constellation’s ability to capture upside from tightening power market conditions.
The nation’s top technology firms have set goals to power this growth with clean and dependable energy.
Growing recognition of nuclear energy as a reliable clean energy resource creates opportunities for Constellation to forge new customer relationships and capture additional value from our 180 million MWh of annual clean energy output.

Netsmart Supports Whole-Person Care Provisions in 42 CFR Part 2 Final Rule

Retrieved on:

Tuesday, February 20, 2024

Strengthens penalties by applying the same requirements of the HIPAA Breach Notification Rule to breaches of records under Part 2.

Key Points:

Strengthens penalties by applying the same requirements of the HIPAA Breach Notification Rule to breaches of records under Part 2.
As a founding member of The Partnership to Amend 42 CFR Part 2 , Scalia stated the long-awaited Final Rule is another step forward for coordinated, whole-person care for individuals nationwide.
These major changes to 42 CFR Part 2 will take effect on February 16, 2026.
To learn more about these regulation changes, read the 42 CFR Part 2 Final Rule Fact Sheet and register for the upcoming Netsmart webinar on Thursday, March 28 at 1 p.m.

Tenet Energy Receives Invitation from U.S. Department of Energy to Submit Part II Application for Electric Vehicle Title 17 Loan

Retrieved on:

Thursday, February 15, 2024

Tenet Energy Inc. (“Tenet”), a climate financial technology platform to accelerate America’s sustainable energy transition, starting with electric vehicles, announced today that the U.S. Department of Energy (“DOE”) has invited the Company to submit the Part II loan application under the DOE Title 17 program for Tenet’s EV Auto Lending project.

Key Points:

Tenet Energy Inc. (“Tenet”), a climate financial technology platform to accelerate America’s sustainable energy transition, starting with electric vehicles, announced today that the U.S. Department of Energy (“DOE”) has invited the Company to submit the Part II loan application under the DOE Title 17 program for Tenet’s EV Auto Lending project.
“This progress lets us be closer to unlocking a path of accessibility and affordability for electric vehicles nationwide.
Tenet will continue to work on advancing the DOE Title 17 process during 2024 and will provide further updates as appropriate.
The foregoing matters are wholly dependent on the results of DOE review and evaluation of a Part II application, and DOE's determination whether to proceed.

Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia

Retrieved on:

Monday, February 12, 2024

“Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial experienced important and clinically meaningful improvements for their daily lives.

Key Points:

“Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial experienced important and clinically meaningful improvements for their daily lives.
At the end of the 48-week study, patients who received SKYCLARYS had significantly improved modified Friedreich Ataxia Rating Scale (mFARS) scores relative to placebo.
Biogen is committed to working closely with all stakeholders to ensure that eligible European patients can have access to this treatment.
SKYCLARYS is also approved for use in the United States, and Biogen is engaging with regulatory authorities in other regions.