Several major issues of GMP in the pharmaceutical industry

Several major issues of GMP in the pharmaceutical industry

From the perspective of the development of the pharmaceutical industry and prospects, pharmaceutical enterprises only in accordance with the pharmaceutical production quality management standards for continuous self-renewal of self-management and self-monitoring, pharmaceutical companies to keep up with the trend of development, in order to produce safe and effective pharmaceutical products in line with market demand. In short, the GMP for pharmaceutical companies’ production, production quality control and management and production process to strengthen the regulation and supervision is actually a meas of urging companies reform themselves and comply with the market.

Quality control and assurance is important guarantee to ensure that Chinese pharmaceutical companies produce products that meet market testing standards. Which issues will be highlighted in the GMP inspection? The main ones are as follows. 
GMP stipulates that the managers of pharmaceutical companies must have a good awareness of drug quality management and must have a good understanding of national regulation and rules. There is also an important review of QA personnel, which require QA personnel to supervise the production process in a standardized manner and to take regular samples for testing, etc.
The second issue involved is the material problem. The material issue here is not only the quality of API required in the production of finished formulations, but also involves the management of APIs and finished formulation materials. For example, whether the API and formulation raw materials are properly preserved, whether there is a lack of relevant standard substances, whether the material suppliers have the relevant qualifications, whether the quality is acceptable.
The third issue is related to laws and regulations that require manufactures of preparations and API to conduct full inspection of finished products in accordance with relevant quality standards. Specific full inspection includes testing pesticide residues, detection of heavy metals and harmful elements, as well as microbiological examination. The methods of testing must be used in accordance with the quality standards.
The last issue involved is that of production equipment and environment. The GMP inspection requirements for preparation and API production equipment are relatively strict, and Chinese pharmaceutical companies must be equipped with a full range of drug production equipment and testing instruments under GMP requirements, and not only that, but API and finished formulations manufactures must also configure and regularly maintain these equipment. Environmental issues refer to the GMP compliance of the production environment and transportation of API and preparations, such as laboratory air conditioning systems, safety cabinets, and product transportation processes.


China pharmaceutical companies need to pay attention to quality assurance in their daily work, strengthen the awareness of risk management, allocate recourse rationally and continuously improve the ability of practitioners to perform their duties, so as to release the capacity potential of China pharmaceutical companies and China finished formulations companies to the greatest extent.