Over-the-counter products
Often marketed as dietary supplements: ISO 9001, HACCP, ISO 17025 (testing).
Production
Development and production of cannabis products – from dietary supplements (ISO 9001, HACCP) to medicinal substances and extracts under EU-GMP.
Vision
To assist with the development and customisation of products with medicinal effect for individual applications (IPLP).
We apply the highest standards for manufacturing and testing – from over-the-counter products to medicinal substances and preparations of EU-GMP quality.
Our standards
We apply the highest standards for manufacturing and testing
Medicinal substances and preparations
The highest quality requirements of pharmacopoeias – ČL (Czech Pharmacopoeia), DAB (Deutsches Arzneibuch), Ph. Eur. (European Pharmacopoeia) – and other legislative regulations, often specific to EU countries, to achieve EU-GMP quality.
We hold SÚKL certifications
State Institute for Drug Control
Important note
The great popularity of cannabis in general requires the consistent application of the necessary standards. However, many of them are not universally accepted, so it is essential to communicate local requirements very well. Furthermore, regulatory measures regarding controlled substances, especially THC, need to be respected.
Our production rules
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We strictly carry out any production in a legal manner. We do not carry out production or testing without provable documentation of production in accordance with Czech legislation.
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As a rule, we start from our own plant sources. Where clients have quality plant sources, these may be used, but must meet quality specifications, logistics conditions and minimum quantities.
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We consistently meet the requirements of regulatory authorities and certification bodies, such as local FDAs, especially where we work in the field of medicinal cannabis.
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We respect the requirements of DG SANTE for the Novel Foods Directive, although we are not without reservations and believe in a positive shift in its restrictive nature. We have nevertheless implemented the relevant registration steps.
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In the absence of standards, we have brought many of our own, which we have validated. We reserve the right to maintain appropriate confidentiality about their details; these procedures do not automatically transfer to the ownership of the products produced.
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We believe that the maximum effect of plants, including cannabis, comes from their overall composition. Therefore we prefer, and recommend to our clients, full-spectrum products.
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We switch to isolated forms of active ingredients when warranted.
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We combine our manufacturing processes exclusively with our own analytical procedures. Tests carried out by third parties are respected, but are indicative for us.
EU-GMP
production and testing of medicinal substances
ISO 9001
and HACCP for over-the-counter products
ISO 17025
accredited testing
ISO 9001 / HACCP production scheme
Over-the-counter products and dietary supplements
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1
Input of grown raw material
The raw material is dried, the seeds are removed and part of the plant (often the flowers) is cut to the optimum fraction size. The treated raw material is stored safely (bags, boxes) in a dry place.
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2
Testing of the raw material
The quality of the raw material is tested; the essential step is the selection of a representative sample. This is the basis for the pilot production of the crude extract.
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3
Crude extract (RA)
The crude extract is the input to the optimal composition of the product portfolio from a specific plant.
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4
Purification
80 % of crude extracts must be comprehensively purified. Without this, PAHs, PCBs, PCDD/Fs, OCPs and similar, often non-polar substances may be present in the extract, especially if the active ingredients are preserved in a non-polar resin. The most common contamination is PAH and PCDD/F (plants grown outdoors); we have also confirmed cases of PCB or OCP contamination.
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5
Purified extract (PE)
Our purified extracts are the basis for the final production of high-quality products.
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6
Filling, packaging and distribution
The products are filled into suitable packaging, packed and distributed to end clients (e.g. via e-shop) or handed over for the client’s own distribution.
GMP production scheme for medicinal cannabis substances
Standardised extracts for IPLP preparation
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1
Input of GMP-quality raw material
Dried raw material is used and, if necessary, adjusted to the optimal fraction size.
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2
Testing under GMP
The quality of the raw material is tested under GMP according to established specifications.
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3
Crude extract (RA)
The crude extract is produced by a validated process.
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4
Multi-step purification
The crude extract is purified in several steps. The degree of purification is chosen according to the required quality / specification of the standardised extract.
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5
Purified extract for IPLP
The purified extract is ready for the manufacture of medicinal products under the IPLP regime.
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6
IPLP preparation in the pharmacy
IPLP preparations are generally prepared in pharmacies.
Download
Dispatch form and sample documentation
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Development and production of your own products
Custom production is rather complex and requires a detailed understanding of your requirements as well as the technological and legislative possibilities – legislation in the field of cannabis is not yet sufficiently settled and clear. Write to us at info@ehss.eu.