GAP (Excerpt from "Good Manufacturing Practice for Chinese Medicinal Materials"

Article 5 Enterprises shall, based on the production characteristics of Chinese medicinal materials, identify the key links that affect the quality of Chinese medicinal materials, conduct quality risk assessments, and formulate effective production management, quality control and preventive measures.

Article 6 Enterprises shall establish an effective supervision and management mechanism for the main production units of the base, realize on-site guidance, supervision and record-keeping of key links; unify the planning of production bases, unify the supply of seeds, seedlings or other breeding materials, unify the management measures for inputs such as fertilizers, pesticides or feed, veterinary drugs, unify the planting or breeding technical procedures, unify the harvesting and production area processing technical procedures, and unify the packaging and storage technical procedures.

Article 7 Enterprises shall be equipped with personnel, facilities, equipment, etc. that are commensurate with the scale of the production base to ensure the smooth implementation of production and quality management measures.

Article 8 Enterprises shall clearly identify the production batches of Chinese medicinal materials and ensure the consistency and traceability of the quality of each batch of Chinese medicinal materials.

Article 9 Enterprises shall establish a quality traceability system for Chinese medicinal materials production to ensure that key links in the entire process, from production sites, seeds and seedlings or other propagation materials, planting and breeding, harvesting and processing at the place of origin, packaging, storage and transportation to shipment, can be traced; enterprises are encouraged to use modern information technology to build traceability systems.

Article 10 Enterprises shall formulate production technical regulations for the following major links in accordance with the requirements of this specification and in combination with production practice and scientific research:

1. Site selection of production base;

(2) Requirements for seeds, seedlings or other propagation materials;

(3) Planting (including ecological planting, wild cultivation and simulated wild cultivation) and breeding;

(iv) harvesting and processing at the place of origin;

(V) Packaging, release, storage and transportation.

Article 11 Enterprises shall formulate quality standards for Chinese medicinal materials, and the standards shall not be lower than the current statutory standards.

(1) Determine the quality control indicators based on the actual production situation, which may include: medicinal material properties, inspection items, physical and chemical identification, extracts, fingerprints or characteristic spectra, indicators or the content of active ingredients; control standards for pesticide residues or veterinary drug residues, heavy metals and harmful elements, mycotoxins and other toxic and harmful substances in medicinal materials;

(ii) When necessary, quality standards for Chinese medicinal materials in the intermediate links such as harvesting, processing and purchasing may be formulated.

Article 12 Enterprises shall formulate standards for seeds, seedlings or other propagation materials of Chinese medicinal materials.