The producer should maintain its standard operating pro-cedures for production and quality management. Detailed records for the entire production process of each crude drug should be documented, and if necessary, photos or images might be attached, which should include, origin of seeds, strains and propagation materials.
DOCUMENTATION
The producer should maintain its standard operating
procedures for production and quality management. Detailed records for the
entire production process of each crude drug should be documented, and if
necessary, photos or images might be attached, which should include, origin of
seeds, strains and propagation materials, production techniques and process,
sowing time, quantity and area of medicinal plants, seedling, transplantation,
and the type, application schedule, quantity arid usage of fertilizer,
quantity, application schedule and usage of pesticide, microbicide or
herbicide, Collection time and yield, fresh weight and processing, drying and
drying loss, transport and storage of medicinal parts. Quality evaluations of
crude drugs: description of macroscopic characters of crude drugs and records
of test results. All these records, production plans and their details,
contracts or agreements etc. should be filed and kept properly by a designated
person.
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