According to the China Chamber of Commerce for the Import and Export of Medicines and Health Products, a few days ago, the European Union officially announced the appendix 7 of the revised GMP Guidelines for Human Use of Medicines and Veterinary Drugs. This section deals with herbal medicines, covering principles, plant and equipment, documentation, and quality control, with particular provisions for the control, storage, and processing of the starting materials. The revised version will be implemented from September 1, 2009. Experts from the Medicare Chamber of Commerce believe that the revision of the GMP for herbal medicines means that the EU has further increased the entry threshold for herbal medicines.
It is understood that in the revised part of the principle, it is clearly defined that the starting material in the manufacture of herbal medicines can be medicinal plants, herbal substances or herbal preparations. In the provisions for plant and equipment, it was emphasized that herbal substances should be stored in isolated areas to prevent insect bites, fermentation, mildew, and cross-contamination, and proposed for cleanliness, humidity, temperature, protection from light, and surveillance. Requirements; in the production area, emphasis is placed on dust removal systems, special workshops, etc.; equipment used in the manufacturing process, filter materials, etc., must be compatible with the extraction solvent to prevent any substances from being released into the solvent, or Any substance is adsorbed on the equipment or filter material, thereby affecting the product quality.
The requirements for the file system require a detailed description of the starting material, including the supplier’s audit records, whether the supplier complies with good planting and collection regulations, etc.; in terms of specification standards, various names, source details, drying systems, Identification of experiments, moisture regulations, microbial contamination, toxic metals and similar contaminants, analysis of active ingredient content, determination of foreign substances, etc.; in terms of process instructions, it is required to record all operating procedures, container inspections, screening methods, etc. The manufacturer records the details of the solvent, time, temperature, etc., as well as detailed concentration steps and methods used.
The requirements for quality control are mainly related to sampling requirements, such as the professionalism of personnel and the relevant regulations for control samples.
Experts from the Medicare Chamber of Commerce believe that with the continuous expansion of the market demand for EU herbal medicines, the relevant market supervision will become more and more stringent. If Chinese companies want to enter this market, they must always pay attention to relevant information and strictly follow their requirements. Regulate production and management, especially in relation to standards, and make preparations as early as possible.
It is understood that in the revised part of the principle, it is clearly defined that the starting material in the manufacture of herbal medicines can be medicinal plants, herbal substances or herbal preparations. In the provisions for plant and equipment, it was emphasized that herbal substances should be stored in isolated areas to prevent insect bites, fermentation, mildew, and cross-contamination, and proposed for cleanliness, humidity, temperature, protection from light, and surveillance. Requirements; in the production area, emphasis is placed on dust removal systems, special workshops, etc.; equipment used in the manufacturing process, filter materials, etc., must be compatible with the extraction solvent to prevent any substances from being released into the solvent, or Any substance is adsorbed on the equipment or filter material, thereby affecting the product quality.
The requirements for the file system require a detailed description of the starting material, including the supplier’s audit records, whether the supplier complies with good planting and collection regulations, etc.; in terms of specification standards, various names, source details, drying systems, Identification of experiments, moisture regulations, microbial contamination, toxic metals and similar contaminants, analysis of active ingredient content, determination of foreign substances, etc.; in terms of process instructions, it is required to record all operating procedures, container inspections, screening methods, etc. The manufacturer records the details of the solvent, time, temperature, etc., as well as detailed concentration steps and methods used.
The requirements for quality control are mainly related to sampling requirements, such as the professionalism of personnel and the relevant regulations for control samples.
Experts from the Medicare Chamber of Commerce believe that with the continuous expansion of the market demand for EU herbal medicines, the relevant market supervision will become more and more stringent. If Chinese companies want to enter this market, they must always pay attention to relevant information and strictly follow their requirements. Regulate production and management, especially in relation to standards, and make preparations as early as possible.
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