On the Quality Assurance of Pharmaceutical Factory

QA is not a quality inspector, especially a pharmaceutical factory.

The full name of QA is translated into quality assurance. As the name implies, it is to ensure that the quality of products and production processes can meet the requirements of laws, regulations and industry standards, and it has the function of monitoring production and quality-related processes. Therefore, QA should not only be very familiar with production links and operation processes, but also have solid and rich knowledge of laws, regulations and SOP, as well as quality management awareness such as standardization and risk control, and have strong ability to judge and solve problems.

Production operations, in most domestic pharmaceutical factories, are only carried out in accordance with fixed operating norms. Although it is not subordinate to QA at the administrative level, QA has the right to stop, correct, train and improve the behavior of operators who violate SOP and laws and regulations.

Therefore, QA needs more comprehensive knowledge and skills, as well as higher awareness of quality and norms.

I hope my answer can help you solve your doubts.