Quality Management

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Chapter: Pharmacognosy and Phytochemistry : Cultivation, Collection and Processing of Herbal Drugs

The herbal drug manufacturers should establish a quality management department which is responsible for supervi-sion and quality control for the entire production process, and should have adequate staff, premises, instruments and equipment to meet the standard requirements of the scale of production and species identification.


QUALITY MANAGEMENT

 

 

The herbal drug manufacturers should establish a quality management department which is responsible for supervision and quality control for the entire production process, and should have adequate staff, premises, instruments and equipment to meet the standard requirements of the scale of production and species identification. The quality management department should monitor the environment and hygienic management, test production materials, packaging materials and the crude drugs, and issue testing reports, develop training plans and supervise their implementation; and also they should manage the original records of production, packaging, testing, etc. Prior to packaging, the quality control department should test each batch of the crude drugs in accordance with the national or approved standards for crude drugs. The testing procedures should include macroscopic characters and identification, impurities, moisture, ash and acid insoluble ash, extracts, and assay for marker or active constituents. Pesticide residue, heavy metals and microbiological limits should comply with the national standards and the relevant requirements. The testing reports should be signed by the operator and the responsible person of the quality control department, and then filed. As far as the personnel and facilities are concerned, they should possess qualifications of college education or above in pharmacy, knowledge in alternative systems of medicines, agronomy, animal husbandry or the relevant specialties, trained on production techniques, safety, and hygiene and have experience in the production of crude drugs, quality management of crude drugs. Staff engaged in the field work should be familiar with cultivation techniques, especially the use of pesticides and safety protection; those engaged in rearing should be familiar with rearing techniques.

 

The personnel engaged in processing, packaging or testing should undergo health examinations regularly and those suffering from infectious diseases, dermatitis or open wounds shall not be allowed to do work which is in direct contact with crude drugs. The producer should designate a person to be responsible for checking sanitation and hygiene. The applicable range and precision of instruments, metres, measures, weighers and balances, etc. used in production and testing, should conform to the relevant requirements, their performance status should be clearly indicated, and calibration should be conducted regularly.

 

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