GMP requires food manufacturers to have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that the quality of the final product (including food safety and hygiene) meets the requirements of regulations. So, the new concept of drug GMP is new?
The new concept of drug GMP is new?
Pharmaceutical GMP has introduced a new concept of quality management in the contemporary world. For example, new concepts such as quality risk management and quality management system will guide China's pharmaceutical companies to implement drug GMP on the basis of science and risk management, which is a new breakthrough in the concept of the domestic pharmaceutical industry.
Taking quality risk management as an example, the pollution, cross-contamination, confusion and errors in the drug production process are not simply found by inspection in accordance with the quality standards of the product. The drug can be released after passing the inspection".
Taking the quality management system as an example, the drug GMP clearly requires that the pharmaceutical company should establish, systematic, and strict quality management system and must allocate sufficient resources to ensure the effective operation of the quality management system, and also emphasizes the quality responsibility of senior management including legal persons and enterprise leaders, which makes the quality management of pharmaceutical enterprises more in-depth, which is not only a great negation of the misconception that "quality management or the implementation of drug GMP is only the responsibility of the quality department or quality management personnel", but also a great negationThe specific implementation of "the enterprise is the person responsible for drug quality" embodies the modern enterprise management concept of institutionalized management.
The above is the introduction of the new concept of drug GMP, which is very important for pharmaceutical companies. If pharmaceutical companies want to carry out GMP certification of drugs, they can consult with us Shandong Famokang.