Table 1- 1 Basic Contents of "Quality Management Standard for Chinese Herbal Medicine Production (Trial)"
Table 1- 1 Basic Contents of Quality Management Standard for Chinese Herbal Medicine Production (Trial) (continued)-1
(1) ecological environment of the place of origin Chinese herbal medicine production enterprises must test the atmospheric, water quality and soil environmental conditions, and all environmental indicators should meet the corresponding national standards.
(2) Germplasm and propagation materials shall accurately identify the species of wild, cultivated or collected medicinal plants and animals, including subspecies, varieties or varieties; The inspection and quarantine system shall be implemented for seeds, breeding animals (animal species) and other propagating materials in the process of production, storage and transportation; Strengthen the breeding of Chinese herbal medicines and establish a breeding base for improved varieties.
(3) Cultivation and aquaculture management According to the habits of various medicinal plants (animals), determine the suitable production area and try to avoid the interference of adverse environment. Formulate technical standard operating procedures (SOP) for planting (breeding) medicinal plants (animals).
(4) Harvest includes the determination of medicinal parts, so as to minimize the mixing of non-medicinal parts or foreign bodies (especially toxic weeds); Study and determination of the best harvest time; Harvesting machinery and tools should be dry, clean and pollution-free.
(5) Primary processing or origin processing refers to the process from medicinal parts to the formation of commercial medicinal materials, excluding the processing of decoction pieces. The purpose of primary processing is to remove foreign bodies, inactivate and dry (except rare medicinal materials) as soon as possible for storage and transportation. The harvested medicinal parts usually need to be cleaned (if it is not suitable for washing, it should be explained) and processed (such as squeezing, drying in the sun, cooking, etc.). ) and do it quickly. Drying equipment must be clean and pollution-free, and operate in strict accordance with the specifications. The dried products should be temporarily spread on the drying rack to prevent mildew and should be packaged as soon as possible.
(6) Check and remove defective products and foreign bodies again before packaging. Packaging materials (bags, boxes, boxes, etc.). ) It should be new or clean, completely dry and undamaged. Fragile medicinal materials should be packed in strong boxes, and toxic and rare medicinal materials should be specially packed with obvious signs and seals.
(7) The transportation and storage of finished medicinal materials should be protected from sun and rain, and fragile medicinal materials should be lightly unloaded. The medicinal materials warehouse should be ventilated, dry and protected from light, and measures should be taken to prevent rats, insects and birds. Finished medicinal materials should be stacked in layers to prevent mildew and deterioration, and checked regularly.
(eight) quality management and quality management departments and personnel must put forward specific requirements for testing items related to the quality of medicinal materials, and unqualified Chinese medicinal materials shall not appear and be sold.
(9) The technical director and the person in charge of the quality management department of the personnel and equipment manufacturing enterprise should have a college degree or above in pharmacy, agronomy or animal husbandry, and have practical experience in the production and quality management of medicinal materials. Relevant personnel engaged in the production of Chinese herbal medicines shall have basic knowledge of Chinese medicine, agriculture or animal husbandry, and receive regular training and assessment in accordance with the requirements of this specification. Chinese herbal medicines should be equipped with toilets or bathrooms.
(10) file management The whole production process of each medicinal material should be recorded in detail, and kept by a special person after being archived.
In order to promote the smooth implementation of Chinese herbal medicine GAP, the State Food and Drug Administration of the United States promulgated the Administrative Measures for Certification of Chinese Herbal Medicine Production Quality Management Standards (Trial) and the Standards for Inspection and Evaluation of Chinese Herbal Medicine GAP Certification (Trial), and officially accepted the application for GAP certification of Chinese herbal medicine on June 5438+065438+ 10/day, 2003. There are 104 GAP certification and inspection items for Chinese herbal medicines, including 9 key items/kloc-0 and 85 general items. Among them, there are 78 inspection items of plant medicinal materials, 5 key items/kloc-0 and 63 general items. The State Food and Drug Administration of the United States organized relevant experts to carry out on-site certification of medicinal plants and animals in the GAP bases of more than 70 Chinese herbal medicine manufacturers, such as Shaanxi Tasly Plant Pharmaceutical Co., Ltd. and Yunnan Te Anna Sanqi Industry Co., Ltd. By the end of 2009, after review and reconsideration procedures, 8 batches have been published, and 65 enterprises, including 48 kinds of medicinal materials and 65 GAP production bases, have officially passed GAP certification (see annex). This indicates that the implementation of GAP has made substantial progress.