Recently, the prices of Chinese herbal medicines have risen as a whole, the cost of Chinese medicines has increased, and the quality and safety risks have increased. To ensure the quality of products, the State Food and Drug Administration issued a notice on December 3, requesting that the supervision and inspection of Chinese medicines be further strengthened, and medicinal materials should be increased. The varieties with large price range, high product cost, and obviously low price in tendering and procurement are listed as the monitoring priorities.
The notification request shall strengthen the supervision and inspection of the purchase of medicinal materials and decoction pieces of Chinese medicine production enterprises, in particular, the purchase channels and relevant qualification certificates of the medicinal materials and decoction pieces of the production enterprises, the audit of suppliers, and the purchase in accordance with the â€œChinese Pharmacopoeiaâ€ (2010 version). The inspection of quality inspections, quality records, etc. of medicinal herbs and decoction pieces will be conducted. Strengthen the supervision and inspection of the implementation of the "Standards for Quality Control of Pharmaceutical Production" (pharmaceutical GMP) in the production process of traditional Chinese medicines to prevent adulteration in the production process. On-site inspections should pay special attention to the feeding conditions of TCM decoction pieces and TCM extracts, pretreatment or extraction of TCM materials, quality control of intermediate products, production records, extraction yield, and material balance.
The circular emphasized that all suppliers who have not audited according to the GMP requirements of pharmaceuticals or have not established a sound medicinal material, a slicer supplier, or purchased quality materials files of herbs and decoctions shall be obliged to rectify immediately; any enterprises that fail to comply with the standard requirements shall be obliged to suspend the enterprise. Production, recall of products already on the market, recovery of the "Drug GMP Certificate" during production stoppages, purchases of extracts that have not been tested or unqualified for the use of raw materials, use of extracts without national standards, unauthorized processing and extraction, and falsification, If shoddy, non-medicinal materials are used to impersonate medicinal materials, unauthorized changes to prescriptions, or violations of the production process, they must be severely punished according to law until the Pharmaceutical Production Permit is revoked; if a crime is suspected, it shall be immediately transferred to the public security agency for investigation of its criminal liability.
The main component of this preparation is human immunoglobulin, which is prepared by cold ethanol fractionation of human plasma from healthy donors. The manufacturing process contains a step to remove anticomplementary activity and a dual viral inactivation process. It contains a suitable amount of glucose or maltose as stabilizer (see table below), but does not contain any antiseptic or antibiotic. The distribution of IgG subclasses is close to the serum level of normal subjects and maintains the bioactivity of Fc fragment of IgG.
agammaglobulinemia, such as X-linked hypogammaglobulinemia,
common variant immunodeficiency diseases, immunoglobulin G subclass deficiency,
immunoglobulin deficiency diseases, such as severe infection, septicemia of
1. Primary agammaglobulinemia, such as X-linked hypogammaglobulinemia, common variant immunodeficiency diseases, immunoglobulin G subclass deficiency, etc.
2. Secondary immunoglobulin deficiency diseases, such as severe infection, septicemia of newborn, etc3. Autoimmune diseases, such as primary thrombocytopenic purpura, Kawasaki disease
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