enhance biodiversity
on farms (1.2) |
avoid damage of plants
—apply “collection
rotation”
— consider CITES |
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adequate education
(2.1) |
appropriate education
(2.2) |
— adequate botanical training (4.6)
— collectors must have sufficient knowledge
on plant id (4.7)
— local supervisor to guarantee education,
supervision, documentation (4.8)
— all collectors should be instructed on all environmental issues (4.9) |
— adequate education and/ or experience (Sec.47/1)
— personnel have the knowledge, and proof of
that knowledge, in the form of a diploma,
certificate or degree from a recognized
Canadian or international institution (3.1.1)
— Provide training in good manufacturing
practices (3.1.2) |
— all material must be
botanically identified
(3.1)
— all impurities must
be eliminated
immediately along the
whole production
process (3.3) |
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— all material must be botanically identified
(8.1)
— all impurities must be eliminated
immediately along the whole production
process (8.2) |
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— when plant delivers
best quality (5.1)
— best conditions (5.2)
— watch out for toxic
weeds (5.5)
— eliminate damaged
plants (5.6)
— clean containers (5.7)
— one person in charge
to verify all steps (5.12) |
— right time (3.1)
— best conditions (3.2)
— watch out for toxic weeds (3.4)
— clean containers, tools (3.5)
— one person in charge to verify all steps (3.10) |
— identify supervisor who verifies material (10.1)
— no collection of endangered species (10.3)
— harvest at best quality (11.1)
— exclude damaged plants/ or part of plants from crop (11.2)
— watch out for toxic weed (11.6)
— clean containers (11.7) |
— verify all incoming/ received material/ assess compliances (Sec.44/2)
— Periodically evaluate complete confirmatory testing of at least one lot per material type per supplier per year (Sec.44/3)
— Confirm that all test methods (e.g. chemical, microscopic, organoleptic) provide accurate and consistent results (Sec.44/4) |
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— eliminate foreign matters (6.9)
— one person in charge to verify all steps (6.12) |
— inspect all material (4.9)
— one person in charge to verify all steps (4.12) |
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— control numbers for batches (Sec.49,50/12,13)
— effective measures to prevent and identify foreign matters (Sec.49,50/17,18)
— securely store labels to prevent mix- ups (Sec.49,50/20,22) |
— repeated control for foreign matters (7.1)
— follow European and national labelling regulations (7.3) |
— repeated control for foreign matters (5.1)
— follow European and national labelling regulations (5.3) |
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— ensure effective control to prevent mix- up of material (Sec. 45)
— set up written procedure of transportation (Sec. 49, 50)
— identify lots with numbers (Sec. 49,50) |
— keep field records (10.1)
— early assignment of batch number (10.4)
— keep batch processing records (10.5 and 10.6)
— mix of material only when perfectly similar (10.8)
— material on the way with a way bill (10.11) |
— collect general data (8.1)
— early assignment of batch number (8.2)
— keep batch processing records (8.4)
— mix of material only under perfect similar conditions (8.6)
— material on the way with a way bill (8.9) |
— all processes must be documented (7.1)
— document location of cultivation (7.3)
— early assignment of batch number (7.7)
— only mix homogenous material, and document that (7.8) |
— Retain a sample of each lot of a finished product (Sec.61/1)
— Ensure that samples are of sufficient size to permit complete testing according to specifications (Sec 61/4)
— maintain records of any testing conducted (Sec.53/c,d) |
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| — organisation should educate their personnel (11.1) |
— organisation should educate their personnel (9.1) |
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— Manufacturers, packagers, labellers, importers and distributors must have quality assurance person (Sec. 51/1)
— to establish written proof on testing, inspections
— to approve test methods and results (3)
— to approve all (incoming) plant identifications along the production (4)
— to ensure complete batch records (5)
— specifications for raw and/or packaging materials must include plant id (Sec.44/1)
—Set up and follow written procedures that describe tests to be conducted to ensure the identity (Sec.44/10) |
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— Establish written procedures that define controls to ensure the effective recall of a product (Sec.49,50/27) |
| — lack of training for personnel to be qualified for microscopic and organoleptic identification of plants |
— growers and producers should have adequate training and knowledge of the medicinal plant
— training should be conducted regularly |
— Persons in charge of quality contol should have at least two years of higher education training and experience in quality control |
— training for all personnel handling or managing crops by experts from local agricultural institute or buyers is highly recommended |
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— identity verified and recorded (incl. common, English and botanical names)
— provide the name of cultivar and supplier
— organic material needs to be certified
— avoid adulterations |
— species, subspecies and variety or type should be accurately identified |
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— harvest at the right time
— avoid adulterations with foreign matters
— if harvested from the wild, set up a collection management plan which includes species id etc.
— use photographs or other illustrated material to harvest from the field
— use botanical keys and other taxonomic information to identify species that are similar to the target plant and grow close to it
— newly introduced species should be identified and documented as the source material used an described in traditional medicine |
— efforts should be made to remove and avoid foreign matters during harvest and primary processing |
— all containers used for harvesting must be kept clean from previous plant material |
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— prior to primary processing, a visual and organoleptic inspection for cross contamination and right identification should be conducted |
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| — adulteration with inexpensive material may happen to increase weight or the sale of exhausted botanicals |
— continues quality control prior to packaging to avoid foreign material
— clear label incl. scientific name |
— Inspection is necessary before packaging to avoid substandard products and foreign objects |
— all foreign material must be removed |
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— keep containers clean of foreign material |
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— there are numerous bioassays in routine use in academic and pharmaceutical labs that could be adapted to botanicals to identify species and/ or ingredients of finished products
— apply organoleptic practises for identification |
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— collectors should prepare a botanical specimen for submission to herbaria for authenticication
— keep voucher specimen for sufficient period of time
— record the name of person who identified the specimen
— if the plant is not well known to the community, the botanical identification should be recorded and maintained
— keep record of batch packaging
— keep and produce as many photographic images as possible |
— Keep record of batch packaging, including product name, specifications, etc
— before packaging a quality identification should be made and approved by the authorities
— inspection records should be kept on file
— all documents should be kept on file for at least 5 years |
— keeping records of each batch of harvested material is highly desirable |
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Good Agricultural practices
24 November 2003
Good Wild crafting Practices
24 November 2003
“Points to consider on good agricultural and collection practices for starting materials of herbal origin”
2 May 2002,
Natural Health Products Regulations Part 3 – Good manufacturing Practices
valid from 1 January 2004
.
Quality Control and Product Standards: an exploration of current issues in botanical quality, draft
WHO Guidelines for Good Manufacturing and Collection Practises (GACP) for medicinal plants,
Good manufacturing Practises for Traditional Chinese Medicine Materials,
Good Agricultural and Collection Practises for Medicinal Plants
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