Implementing GMPs may ensure the consistent quality of medicinal or herbal substances is derived from cannabis. Its standards are used in the manufacture, processing, packing, and handling of active pharmaceutical ingredients (APIs) as well as medicinal or herbal substances.
Manufacturing and managerial processes and practices that assure that medicinal products meet the appropriate quality standards/marketing authorization criteria, product specifications, and consumer preferences in order to ensure a secure and effective final product are known as Good Manufacturing Practices (GMP).
Some basic principles of GMP include the following:
1) proper design
2) construction and maintenance of the facility
3) utilities and equipment
4) validation of equipment
5) production processes
7) test methods
8) software system
What is cannabis?
Cannabis is known by many names including that of Ganja, weed or grass. THC or tetrahydrocannabinol is the main component of cannabis. It can be used wither for medicinal purposes or for recreational purposes.
Cannabis: Regulatory framework
Cannabis is according a global status in terms of its medicinal uses and the year 2018 witnessed a brilliant shift when numerous countries turned towards legalizing medical cannabis. Up until now only a few countries have recognized cannabis for its recreational use.
Cannabis: manufacturing life cycle
The life cycle of cannabis usually begins by cultivation of the plant. The following steps are involved in the manufacturing cycle of cannabis:
Application of GMP in cultivation of cannabis
Implementing GMPs may ensure the consistent quality of medicinal or herbal substances are derived from cannabis. Its standards are used in the manufacture, processing, packing, and handling of active pharmaceutical ingredients (APIs) as well as medicinal or herbal substances. Check out Homegrown Cannabis Co. for great BOGOs deals on cannabis seeds.
Cannabis production for medicinal purposes may be achieved in an external environment. Medical plant materials derived from the same type of cannabis that are grown and harvested in external conditions may have major differences in nature, such as physical appearance and composition, depending on external environmental conditions, such as ecological and geographical parameters. The following GMP certification requirements must be kept in mind:
1) Assurance of quality: Contract terms written between producers and buyers of high-quality medicinal plants/herbal substances extracted from cannabis should adhere to national or regional requirements.
2) Responsibility of manager: Every manager should be fully informed of his responsibilities for maintaining a secure and healthy working atmosphere, as well as having the requisite qualifications to achieve the objectives set forth.
3) Premises: According to national law, all facilities and sites used for cannabis production and primary processing must have a valid permit. Structures used to handle medicinal herbs/cannabis herbal substances must be hygienic, well ventilated, and have good foundations, and they should not ever be used for livestock storage.
4) Equipment: Plant harvesting and processing equipment and machines should be made of chemical and other undesirable substance resistant materials, washed, maintained, and calibrated on a regular basis, and should be readily available.
5) Training: Each batch of medicinal plants or herbal materials derived from cannabis must have its cultivation and processing protocols approved by a qualified agronomist and pharmacist, and it must be stored for at least ten years.
6) Hygiene: Both cultivation and primary treatment processes shall adhere to all national or regional food safety and staff hygiene regulations. Personnel should really be expected to maintain a high degree of personal hygiene and undergo adequate hygienic training.
7) Documentation: All procedures involving cultivated medicinal cannabis substances should be documented, including the site, the details of the appropriate agronomist and pharmacist, the normal cultivation conditions, the type of medicinal cannabis substances, the quantity and duration of harvest, as well as the chemicals and other materials used during processing.
8) Seeds and related material: The seed should come from a medicinal herb that has been precisely expressed in terms of yield, species, diversity, and origin, and it should be tracked.
9) Cultivation: The following principles of successful cultivation must be followed:
i) Climate and the environment
· Water supply
· Sunlight duration
ii) Soil fertility:
· Organic matter
iii) Fertilizer application
v) Protection of plants and its maintenance
10) Harvest: It's important to find out when the best time is to grow cannabis for medical purposes. Plants or part of plants that have been damaged should be discarded. Cannabis should not be mixed with other plant species or cannabis types, or collected cannabis should not be mixed with harmful weeds.
11) Waste management: Waste and contamination risk assessments, as well as the handling of hazardous materials and chemicals, should all be recorded. It is important to put in place a written strategy for waste reduction and careful dislocation outside the site.
12) Packaging: Cannabis for medicinal purposes should be packaged in clean, dried, ideally new boxes made of aluminum and labelled with evident, permanently attached, non-toxic material labels.
Cannabis is yet to be legalized in many countries for its medicinal properties. Good manufacturing practices and production of cannabis must go hand in hand so that it is safely produce, stored and transported.