SCOPE | 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

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.

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.

Medidata Wins Inaugural SCOPE Site Innovation Award for Pioneering Advancements in Site Experience with Leading-Edge Technology

Retrieved on:

Tuesday, March 26, 2024

Medidata , a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, was presented with the inaugural Site Innovation Award for its groundbreaking work in improving efficiency in clinical trials by the Summit for Clinical Ops Executives (SCOPE).

Key Points:

Medidata , a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, was presented with the inaugural Site Innovation Award for its groundbreaking work in improving efficiency in clinical trials by the Summit for Clinical Ops Executives (SCOPE).
Medidata Rave Companion was selected as the winner for its ability to elevate the site experience, enabling sites to spend more time conducting research, caring for patients, and delivering high-quality data to sponsors.
In fact, one clinical trial site reported that data entry was 44 times faster with Rave Companion than doing it manually.
“We’re honored to receive the Site Innovation Award and to be recognized by SCOPE,” said Dan Braga, vice president, electronic health record and healthcare solutions, Medidata.

ScienceMedia Welcomes Visionary Leaders to Advisory Board, Paving the Way for a New Era of Innovation

Retrieved on:

Thursday, March 21, 2024

SCOPE, Software as a service, Growth, AstraZeneca, Patient, SAN, Acquisition, Corporate Affairs, Senior, Clinical trial, Therapy, Summit, Medical writing, Pharmaceutical industry

Their unparalleled insights—from patient-centric approaches to cutting-edge AI advancements—will fuel our mission to drive a transformative revolution in clinical trials."

Key Points:

Their unparalleled insights—from patient-centric approaches to cutting-edge AI advancements—will fuel our mission to drive a transformative revolution in clinical trials."
Their insight will accelerate our growth and allow us to continue solving the most challenging therapeutic and clinical issues facing the industry."
Bierstein continues, "Embracing the spirit of innovation and collaboration, our esteemed advisory board represents the vanguard of change in the pharmaceutical and biotech sectors.
For further insights into ScienceMedia's groundbreaking initiatives and the dawn of a new era in clinical mastery, click here .

OneMedNet iRWD® Draws Attention at Clinical Trials Meeting

Retrieved on:

Monday, February 12, 2024

Medical device, Pharma, SCOPE, Real world data, Patient, Organization, Medicine, Health, Real

SCOPE is based on the premise that “Clinical trials and clinical research are essential for advancing medical knowledge, improving patient care, and developing new treatments and therapies for the patients who need them.”

Key Points:

SCOPE is based on the premise that “Clinical trials and clinical research are essential for advancing medical knowledge, improving patient care, and developing new treatments and therapies for the patients who need them.”
Over 4,000 attendees from 850 organizations and 27 different countries are in attendance to collaborate on solving the challenges of data access and diversity optimization in clinical trials.
“We are excited to engage with our existing customers and partner with new ones over the next two days,” stated Aaron Green, OneMedNet President.
“These include Clinical Research Organizations and Life Science companies (including Pharma and Medical Device) - who are all highly motivated to expand patient insight using Real World Data.
We intend to increase awareness of our solutions that provide seamless access to high quality, de-identified patient data in near real-time.”

WCG ClinSphere™: Revolutionizing Clinical Research Technology

Retrieved on:

Monday, February 12, 2024

Sphere, WCG, Doctor of Philosophy, Artificial intelligence, AI, Intelligence, FDA, SCOPE, ChromeOS, Seamless, Clinical trial, Agility, Lithium, Pharmaceutical industry

PRINCETON, N.J., Feb. 12, 2024 /PRNewswire/ -- WCG, the global leader in providing solutions that measurably improve and accelerate clinical research, announces the upcoming launch of WCG ClinSphere™ , a revolutionary technology platform designed to enable an efficient and optimized clinical research process by leveraging data, insights, and artificial intelligence to connect sites, sponsors, CROs, and participants on a unified, cloud-based system.

Key Points:

PRINCETON, N.J., Feb. 12, 2024 /PRNewswire/ -- WCG, the global leader in providing solutions that measurably improve and accelerate clinical research, announces the upcoming launch of WCG ClinSphere™ , a revolutionary technology platform designed to enable an efficient and optimized clinical research process by leveraging data, insights, and artificial intelligence to connect sites, sponsors, CROs, and participants on a unified, cloud-based system.
WCG ClinSphere is poised to reimagine traditional clinical research processes with its advanced capabilities, accelerating research timelines, streamlining workflows, and strengthening collaboration throughout the clinical research ecosystem.
WCG's Chief Technology Officer, Paul Mancinelli, PhD, added, "WCG ClinSphere is the culmination of cutting-edge technology and years of expertise in the clinical research domain.
Embodying WCG's commitment to efficiency and optimization in clinical trials, the name "Clin" aptly reflects its core purpose in clinical research.

Datacubed Health Announces eCOA and Technology expert Vikram Natarajan, as the new CTO

Retrieved on:

Monday, February 12, 2024

American Opportunity Tax Credit, Knowledge, Health, SCOPE, Growth, Vikram, Management

King of Prussia, PA, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Datacubed Health is excited to announce the appointment of Mr. Vikram Natarajan as its new Chief Technology Officer (CTO).

Key Points:

King of Prussia, PA, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Datacubed Health is excited to announce the appointment of Mr. Vikram Natarajan as its new Chief Technology Officer (CTO).
Vikram Natarajan's arrival at Datacubed Health marks a pivotal moment for the company, as he brings strategic leadership and technological vision that aligns seamlessly with the company's commitment to advancing digital health solutions.
Before joining Datacubed Health, Vikram held key leadership roles, leading product and technology teams to new heights.
"We are excited to welcome Vikram Natarajan to Datacubed Health as our Chief Technology Officer," said Brett Kleger, Chief Executive Officer at Datacubed Health.

ClinEco Launches ClinEco Commons - One Centralized Hub to Access Volumes of Clinical Research News, Insights, and Other Resources

Retrieved on:

Friday, February 9, 2024

Online, Knowledge, SCOPE, Innovation, Community, News, Commons, Ecosystem, Clinical trial, Entrepreneurship, Business

NEEDHAM, Mass., Feb. 9, 2024 /PRNewswire-PRWeb/ -- ClinEco, the world's first online community for clinical trial organizations to explore, engage, and exchange capabilities with an ecosystem of partners, announced today the launch of ClinEco Commons. ClinEco Commons is the latest addition to the growing online community and marketplace. It is designed to be the central resource for clinical research professionals worldwide, offering a comprehensive and easy-to-use portal for critical information and industry expertise.

Key Points:

ClinEco Commons features a vast catalog of resources tailored for clinical research professionals, including webinars, white papers, videos, news, and more.
"ClinEco Commons is the latest example of our commitment to making it easier for research professionals to share ideas and expertise.
ClinEco Commons encourages the sharing of whitepapers, articles, podcasts, and other resources from all members of the ClinEco community, while also providing access to numerous resources from SCOPE.
All members of the ClinEco community will have immediate access to ClinEco Commons.

ScienceMedia Calls Upon Innovators to Join the Revolution at SCOPE

Retrieved on:

Friday, February 9, 2024

Learning, Summit, Trust, Microsoft PowerPoint, ChromeOS, SCOPE, SMI, Science, Empathy, Hatred, Nursing

ScienceMedia will be calling upon all innovators and change agents at SCOPE to join the revolution by breaking free of the PowerPoint status quo, and embracing multimodal learning.

Key Points:

ScienceMedia will be calling upon all innovators and change agents at SCOPE to join the revolution by breaking free of the PowerPoint status quo, and embracing multimodal learning.
It's time for a revolutionary change in the industry, and we are spearheading this much needed revolution."
In addition to launching a revolution at SCOPE, ScienceMedia will be running a "PowerPoint MindNumb vs Multimodal Training" challenge on how sites, teams and CROs prefer to learn complex trial protocols.
Visit ScienceMedia's SCOPE site for more details about the revolution happening at booth #1207.

PicnicHealth Launches New AI-Driven Study Portal to Streamline Observational Research

Retrieved on:

Thursday, February 8, 2024

PicnicHealth , a leading patient-centered healthcare evidence generation company, today announced the launch of a new study portal to facilitate faster, more accurate observational research.

Key Points:

PicnicHealth , a leading patient-centered healthcare evidence generation company, today announced the launch of a new study portal to facilitate faster, more accurate observational research.
PicnicHealth will showcase the capabilities of the new portal at the SCOPE Summit taking place February 11-14, 2024 in Orlando, Fla.
View the full release here: https://www.businesswire.com/news/home/20240208980747/en/
Dashboard showing PicnicStudies recruitment and study progress in newly launched study portal.
“The new portal enables life science companies to easily monitor study enrollment and progression in ways never before possible with traditional site-based observational research,” says Dan Drozd, Chief Medical Officer of PicnicHealth.