Special rectification of Chinese herbal medicine is coming in 2020

Recently, the State Food and Drug Administration released the "Special Remediation Work Plan of Chinese Medicine Decoction Pieces", and the special remediation of Chinese medicine decoction pieces began in 2020.

On March 17, Hubei Provincial Drug Administration issued the "Notice of the Provincial Drug Administration on Printing and Distributing the Special Rectification Work Plan of Hubei Provincial Chinese Medicine Decoction Pieces" E Yao Jian Fa [2020] No. 1.

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In the notice, the Hubei Provincial Drug Administration mentioned that in order to further regulate the production, operation and use of Chinese herbal medicine pieces, continuously improve the quality of Chinese herbal medicine pieces, and severely crack down on violations of laws and regulations, in accordance with the "Special Remediation Work Plan of Traditional Chinese Medicine Pieces" (Drug supervision comprehensive medicine tube [2020] No. 12) requirements, combined with the actual situation in Hubei Province, decided to start from March 2020 to the end of September 2021, a one-and-a-half-year period of special rectification work of Chinese herbal medicines in the province.

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Key points for inspection of Chinese herbal medicine production enterprises:

1. Purchase of Chinese herbal decoction pieces through illegal channels. Check whether there is a call ticket, rent a loan certificate, and entrust or entrust the production of Chinese herbal medicine pieces; check whether there is a case of sub-packaging or changing the packaging label of the intermediate products or finished products of purchased Chinese herbal medicine pieces; check whether there is a change number or a batch number Situation; check whether there is a mismatch between the production capacity of traditional Chinese medicine decoction pieces and the sales quantity, and fabricate production and sales records.

2. The use of unqualified Chinese herbal medicines and Chinese herbal medicines. Check whether a sound supplier audit system is established and audit as required, and select stable and reliable suppliers of Chinese herbal medicines and Chinese herbal medicines; check whether strict internal quality control standards for Chinese herbal medicines and Chinese herbal medicines are formulated and purchase Chinese herbal medicines and Chinese herbal medicines as required Carry out inspection; check whether the quality of purchased Chinese herbal medicines and Chinese herbal medicines are evaluated and establish a quality file; check whether there is any strict control of Chinese herbal medicines and Chinese herbal medicines entering the factory, use doping to make false, dyeing weight increase, moldy, spoiled, contaminated or extracted The situation of the feeding of traditional Chinese medicinal materials and decoction pieces.

3. Implementation of GMP requirements. Check whether there are Chinese medicine technical professionals with the ability to distinguish the authenticity of Chinese herbal medicines and Chinese herbal medicines, and whether the Chinese herbal medicine processing operators have the corresponding professional knowledge and practical skills; check whether they are suitable for the production variety and can meet the production The workshops and facilities, production, inspection equipment and capabilities required by the process; check whether the production areas related to direct oral decoctions meet the management requirements of Class D clean areas; check whether reliable measures are taken to store, maintain, and transport Chinese herbal medicines and decoctions to avoid Pollution and cross-contamination and prevent its quality from deteriorating; check whether production is organized in strict accordance with the requirements of process regulations, relevant standards, processing specifications, etc., whether key process parameters are clear, whether there is the use of Chinese medicinal materials, Chinese medicine extracts instead of Chinese medicine decoction pieces or the use of fake The situation of feeding; check whether there is a situation where the audit trail function is fake and selective use of data.

4. Fulfillment of the relevant obligations of the holder of the listing license. Check whether the production enterprises of Chinese herbal medicines and preparations implement the whole process management of production and sales, whether they establish a traceability system of Chinese herbal medicines to ensure the safety, effectiveness and traceability of Chinese herbal medicines; Trace back.

Source: China Pharmaceutical Network