Medicines are special commodities, which are related to the safety and effectiveness of people's medications and good health. Good quality medicines can cure diseases and save people; inferior medicines can delay the disease and cause death. Therefore, the quality requirements for medicines are not trivial and must be:
Purity requirements. The purity of a drug is an important indicator of the quality of a drug and must comply with national statutory standards.
Uniformity. The production of medicines is large production, some are continuous, some are intermittent, whether continuous production or intermittent production, we require the same batch of medicines, its quality must be uniform and consistent. Otherwise, the sample sample taken for sampling will be unrepresentative, which will affect the accuracy of the drug test results. On the other hand, the content of the preparation product is not uniform, which affects the accuracy of the dosage, which will affect the curative effect and seriously endanger the safety of the patient.
stability. The quality of a drug must remain stable during the period of validity or use, and it will not deteriorate.
begging.
Effectiveness. Under normal circumstances, patients who are taking drugs can have an effective medical effect on the disease.
safety. After taking the medicine, the patient does not have an adverse reaction and has few side effects.
Since the production of medicines is a very complicated process, from the raw materials entering the factory to the finished products being manufactured and leaving the factory, many production links and management are involved. If any one link is negligent, the quality of the drugs may not meet the requirements of the state. In other words, it is possible to produce inferior drugs. Therefore, it is necessary to carry out the management control of the whole process in the process of drug production, in order to ensure the quality of the drug, and to meet the requirements of the above-mentioned drug quality, this can only be achieved by implementing GMP. The practice of more than 30 years has proved that GMP is indeed an effective and advanced scientific management system, especially for eliminating the hidden dangers of pollution, confusion and errors in the production process of drugs, and ensuring the quality of drugs.
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