Abstract
In 2015, in Republic of North Macedonia, a new law for narcotics has been adopted, where the changes include legal cultivation of cannabis for medicinal use as well as legal production of cannabis extracts for medicinal use. In order to gain high quality of cannabis and cannabis products for medicinal use and to meet some quality standards that will guarantee consistency, traceability and continuous quality of the product, it is necessary to implement Quality Systems. Good quality system is ISO standard system but for cannabis for medicinal use, GACP, GMP and GLC standards are used more often. Production of cannabis for medicinal use consists of: process of cultivation where GACP standards are applicable, primary processing where GMP standards are the most important and quality control of final product regulated with GLP standard. In this review, explanation of these standards as well as overview of modes of their implementation has been made. Keywords: GxP, GMP, GACP, GLP
Highlights
Standards present in standardized production for the purpose of obtaining good quality cannabis products through a permanent, unified and stable system are: 1. Good Practices (GxP) ("x" can be replaced by agriculture, revision, documentation, manufacturing, clinical, distribution, laboratory, storage, etc.) are recommended working procedures and methodologies that are applied for gaining effective, accurate, reliable, consistent and pure active substance, medicinal product or2
The production, processing, packaging and storage of active pharmaceutical ingredients (APIs) as well as medicinal plants/herbal substances relies on Good Manufacturing Practices (GMP) standards
The previous sections examined the various requirements of Good Agricultural Practice and Collection Practices (GACP) and GMP, but to be ready for GMP standards, the Primary Cannabis processing as drying, trimming, packing and storage of Cannabis flos 100 g, in-bulk packed in aluminum bags, the following five aspects must be completed: Table 1
Summary
Standards present in standardized production for the purpose of obtaining good quality cannabis products through a permanent, unified and stable system are: 1. Good Practices (GxP) ("x" can be replaced by agriculture, revision, documentation, manufacturing, clinical, distribution, laboratory, storage, etc.) are recommended working procedures and methodologies that are applied for gaining effective, accurate, reliable, consistent and pure active substance, medicinal product or. The production, processing, packaging and storage of active pharmaceutical ingredients (APIs) as well as medicinal plants/herbal substances relies on GMP standards. As a result of the complexity of naturally grown medicinal herbs/herbal substances and limited analytical techniques for determining the ingredients by chemical and biological methods, the repetition of the quality of initial materials of plant origin depends on the appropriate quality assurance system for collection and/or cultivation, harvest and primary processing. GACP provide additional standards for the production and processing of medicinal plants/herbal cannabis substances with a major focus on identifying those critical production steps that are needed to ensure the required quality and safety for consumption. GMP implementation in the cannabis industry is relevant for: primary processing, materials, methods, facilities, equipment, personnel, controls, manufacturing, packaging, storage, documentation and transport. The previous sections examined the various requirements of GACP and GMP, but to be ready for GMP standards, the Primary Cannabis processing as drying, trimming, packing and storage of Cannabis flos 100 g, in-bulk packed in aluminum bags, the following five aspects must be completed:
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