The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants are mainly intended to provide general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines.
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
Role of chemical & biological marker.pptxEasy Concept
Increased herbal medicines use and lack of effective regulatory control, the safety of herbal medicines has become a key priority issue. Herbal drug technology is used for converting botanical materials into medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge is important.
According to regulatory guidelines and pharmacopoeias macroscopic and microscopic evaluation and chemical profiling of the botanical materials is used for quality control and standardization.
Research Guidline safety & efficacy of herbal drug.pptxEasy Concept
The Research guidelines for evaluating the safety and efficacy of herbal medicines are intended to facilitate the work of research scientists and clinicians in this field and to furnish some reference points for the governmental, industrial and non-profit organizations that provide financial support for their work.
It must be emphasized that these guidelines are offered as a summary of scientific standards governing various aspects of the study of herbal medicines.
The European Medicines Agency's (EMAs) Committee for herbal medicinal products for human and veterinary use prepares scientific guidelines in consultation with
regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorization applications for human and veterinary medicines.
WHO guidelines on herbal drug monitoringKaustav Dey
This presentation points out the various guidelines laid out by World health organization for safe & effective way of monitoring of Herbal Medicine in a pharmacovigilance setting
The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants are mainly intended to provide general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines.
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
Role of chemical & biological marker.pptxEasy Concept
Increased herbal medicines use and lack of effective regulatory control, the safety of herbal medicines has become a key priority issue. Herbal drug technology is used for converting botanical materials into medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge is important.
According to regulatory guidelines and pharmacopoeias macroscopic and microscopic evaluation and chemical profiling of the botanical materials is used for quality control and standardization.
Research Guidline safety & efficacy of herbal drug.pptxEasy Concept
The Research guidelines for evaluating the safety and efficacy of herbal medicines are intended to facilitate the work of research scientists and clinicians in this field and to furnish some reference points for the governmental, industrial and non-profit organizations that provide financial support for their work.
It must be emphasized that these guidelines are offered as a summary of scientific standards governing various aspects of the study of herbal medicines.
The European Medicines Agency's (EMAs) Committee for herbal medicinal products for human and veterinary use prepares scientific guidelines in consultation with
regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorization applications for human and veterinary medicines.
WHO guidelines on herbal drug monitoringKaustav Dey
This presentation points out the various guidelines laid out by World health organization for safe & effective way of monitoring of Herbal Medicine in a pharmacovigilance setting
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
WHO to provide technical support to develop a methodology to
monitor or ensure the quality, efficacy and safety of traditional
medicine and its products.
To promote and improve the quality of herbal medicines and
also to reduce the proportion of adverse effect caused by the
poor quality of herbal medicines.
In this power points viewer will be able to know the meaning of Pharmacopoeia and its coposition. History behind the different pharmacopoeia and popular pharmacopoeia existing world wide in herbal medicines. List of different pharmacopoeias also has been included.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
Preparation of documents for Export regd..pptxEasy Concept
A manufacturer holding valid license copy in Form-25 & Form-
28 can obtain No Objection Certificate from Zonal/Sub Zonal
offices of Central Drugs Standard Control Organization (CDSCO) for export purpose only for approved/unapproved new Drugs / banned drug from India.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
A Good Agricultural Practice of medicinal plants is a cultivation program designed to ensure optimal yield in terms of both the quality and quantity of any crop intended for health purposes.
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
WHO to provide technical support to develop a methodology to
monitor or ensure the quality, efficacy and safety of traditional
medicine and its products.
To promote and improve the quality of herbal medicines and
also to reduce the proportion of adverse effect caused by the
poor quality of herbal medicines.
In this power points viewer will be able to know the meaning of Pharmacopoeia and its coposition. History behind the different pharmacopoeia and popular pharmacopoeia existing world wide in herbal medicines. List of different pharmacopoeias also has been included.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
Preparation of documents for Export regd..pptxEasy Concept
A manufacturer holding valid license copy in Form-25 & Form-
28 can obtain No Objection Certificate from Zonal/Sub Zonal
offices of Central Drugs Standard Control Organization (CDSCO) for export purpose only for approved/unapproved new Drugs / banned drug from India.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
Quality control of herbal medicines aims to ensure their consistency, safety and efficacy.
Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines.
A Good Agricultural Practice of medicinal plants is a cultivation program designed to ensure optimal yield in terms of both the quality and quantity of any crop intended for health purposes.
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
Plants Drug Cultivation:
General introduction to importance pharmacognosy.
Indian Council of Agricultural Research.
Current good agricultural practices.
Current good cultivation practices
Current good collection practices.
Conservation of medicinal plants-Ex-situ & In-situ conservation of medicinal plants.
Pharmacognosy is the objective study of crude drugs of animal, vegetable and mineral origin, treated scientifically.
Pharmacognosy is the study of medicine derived from natural sources that include plants, animals, and microorganisms, and the scope of the field depends on knowledge about the safety, purity, and efficacy of complex multicompound products.
Herbal pharmacognosy is the application of this science specifically to traditional herbal medicine sources.
There is a great demand for herbs, hence there is a need to adopt systematic scientific methods for their selection, cultivation, collection, processing and to ensure the quality, purity, safety, potency and develop modern methods for their quality control so that maximum benefit is obtained from these herbal medicines
FSC 503: Biodiversity and conservation of fruit crops
Collection: Tapping of genetic diversity from various sources and assembling at one place is called germplasm collection.
Evaluation: It deals with the assessing the agronomic potential of an accession including quality parameters and response to various abiotic and biotic stresses.
Documentation:Germplasm conservation, in its various stages, includes a range of activities for which information is required or from which information is derived. This may refer to species, their sites of origin, or activities or stages of conservation. The action of recording, organizing, and analyzing conservation data is known as documentation.
This video mainly focused on "Election of Medicinal Plants" which is the part of B. Pharmacy 4th year syllabus PRACTICE SCHOOL, from JNTUH, Hyderabad. The Practice school is an educational innovation seeking to link industry/hospital/ pharmacy experience with university instruction. Here in election of medicinal plants materials topic from quality control and standardisation of herbals subjects The students have to visit medicinal plant gardens and collect some medicinal plants those are useful to various disorders and submit the report in detail about the plants they come across during their study period.
Portion covered :
1. Election of medicinal plants
2. Techniques and methods for selecting medicinal plants.
3. Ethnobotany
4. The ethnopharmaceutical approach
5. Medicinal plants in the basic health care from ethnoguided approach.
Value Addition of Nine Medicinal Plants in Arunachal PradeshSanjay Talukdar
Understood requirements from forest departments and other stakeholders, gathered information, researched, planned & designed the JFMC Proposal for Value Addition of Nine Medicinal Plants for Forest Department of Arunachal Pradesh.
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Who guidelines on good agricultural and collection practices medicinal plants
1. WHO GUIDELINES ON GOOD
AGRICULTURAL AND
COLLECTION PRACTICES ( GACP)
FOR MEDICINAL PLANTS
PRESENTED BY NEHA SODIYAL
1
2. INTRODUCTION
Good agriculture and collection practices for medicinal plants (GACP) are a set of guidelines developed in
2003 by the WHO, with the view to improve the quality of medicinal plant material being used in herbal
medicines.
As per WHO reports, ( 65-80%) of the world’s population seek plants or plant- derived natural products for
various diseases.
To maintain the consistency in demand and medicinal effects of plants GACP provides suitable collection
practices for each medicinal plant species and plant part used ( roots, leaves, fruits etc. )
Raw medicinal plant materials should meet all applicable national/ regional quality standards.
2
3. The main objectives of the GACP guidelines
To contribute to the quality assurance of medicinal plant materials used as the source for herbal
medicines, which aims to improve the quality, safety and efficacy of finished herbal products.
To guide the formulation of national and/or regional GACP guidelines and GACP monographs
for medicinal plants and related standard operating procedures.
To encourage and support the sustainable cultivation and collection of medicinal plants of good
quality in ways that respect and support the conservation of medicinal plants and the
environment in general.
3
4. Some Definitions
Contamination The undesired introduction of impurities of a
chemical or microbiological nature, or of foreign
matter, into or on to a starting material or
intermediate during production, sampling, packaging
or repackaging, storage or transport.
Cross-contamination Contamination of a starting material, intermediate
product or finished product by another starting
material or product during production
Erosion The process whereby water or wind moves soil from
one location to another
Integrated pest management (IPM) The careful integration of a number of available
pest-control techniques that discourage pest-
population development and keep pesticides and
other interventions to levels that are economically
justified and safe for human health and the
environment
4
5. Landrace In plant genetic resources, an early, cultivated form
of a crop species, evolved from a wild population,
and generally composed of a heterogeneous
mixture of genotypes.
Propagule Any structure capable of giving rise to a new plant
by asexual or sexual reproduction, including
bulbils, leaf buds, etc.
Standard operating procedure (SOP) An authorized written procedure giving instructions
for performing an operation.
5
6. Component of GACP for medicinal plants
1. Permission to collect
2. Technical planning
3. Selection of medicinal plants for collection
4. Collection
5. Personnel
6
7. 1. Permission to collect
Sufficient time for the processing and issuance of these permits must be allocated at the planning stage.
In some countries, collection permits and other documents from government authorities and landowners
must be obtained prior to collecting any plants from the wild.
For medicinal plant materials intended for export from the country of collection, export permits,
phytosanitary certificates, Convention on International Trade in Endangered Species of Wild Fauna and
Flora (CITES) permit(s) (for export and import), CITES certificates (for re-export), and other permits must
be obtained, when required.
7
8. 2. Technical planning
Prior to initiating a collection expedition, the geographical distribution and population density of the target
medicinal plant species should be determined.
When the collection sites have been identified, local and/or national collection permits should be obtained.
Essential information on the target species (taxonomy, distribution, phenology, genetic diversity, reproductive
biology and ethnobotany) should be obtained.
Data about environmental conditions, including topography, geology, soil, climate and vegetation at the
prospective collecting site(s), should be collated and presented in a collection management plan.
Research on the morphology of the target medicinal plant species and variability of its populations should be
carried out in order to develop a “search image” for the species.
8
9. Copies of photographs and other illustrations of the target medicinal plant(s) from books and
herbarium specimens, and ethnographical information (common or local names) of the target
species and plant parts are useful field instruments, especially for untrained workers.
Rapid, safe and dependable transportation to carry personnel, equipment, supplies and
collected medicinal plant materials should be arranged in advance.
A collection team familiar with good collecting techniques, transport, and handling of
equipment and medicinal plant materials, including cleaning, drying and storage, should be
assembled.
The social impact of field collection on local communities should be examined and the
ecological impact of field collection activities should be monitored over time.
The stability of the natural habitat(s) and the maintenance of sustainable populations of the
target species in the collection area(s) must be ensured.
9
10. 3. Selection of medicinal plants for collection
Where applicable, the species or botanical variety selected for collection should be the same as that specified
in the national pharmacopoeia or recommended by other authoritative national documents of the end-user's
country, as the source for the herbal medicines concerned.
Collectors of medicinal plants and producers of medicinal plant materials and herbal medicines should
prepare botanical specimens for submission to regional or national herbaria for authentication.
If the medicinal plant is not well known to the community, then documentation of the botanical identity
should be recorded and maintained.
10
11. 4. Collection
Collection practices should ensure the long-term survival of wild populations and their associated habitats.
The population density of the target species at the collection site(s) should be determined and species that are
rare or scarce should not be collected.
Management plans should refer to the species and the plant parts (roots, leaves, fruits, etc.) to be collected
and should specify collection levels and collection practices.
Medicinal plant materials should be collected during the appropriate season or time period to ensure the best
possible quality of both source materials and finished products.
11
12. Only ecologically non-destructive systems of collection should be employed. These will vary
widely from species to species. For example, when collecting roots of trees and bushes, the
main roots should not be cut or dug up, and severing the taproot of trees and bushes should be
avoided.
In the course of collection, efforts should be made to remove parts of the plant that are not
required and foreign matter, in particular toxic weeds. Decomposed medicinal plant materials
should be discarded.
the collected raw medicinal plant materials should not come into direct contact with the soil. If
underground parts (such as the roots) are used, any adhering soil should be removed from the
plants as soon as they are collected.
After collection, the raw medicinal plant materials may be subjected to appropriate
preliminary processing, including elimination of undesirable materials and contaminants,
washing (to remove excess soil), sorting and cutting.
12
13. 5. Personnel
Local experts responsible for the field collection should have formal or informal practical education and
training in plant sciences and have practical experience in fieldwork.
Field personnel should have adequate botanical training, and be able to recognize medicinal plants by their
common names and, ideally, by their scientific (Latin) names.
The collection team should take measures to ensure the welfare and safety of staff and local communities
during all stages of medicinal plant sourcing and trade.
All personnel must be protected from toxic and dermatitis-causing plants, poisonous animals and disease-
carrying insects. Appropriate protective clothing, including gloves, should be worn when necessary.
13