Pharmaceutical companies through the two systems of re-certification and review.
From November 20 to 23, the audit team organized by the third-party audit agency Wantai Certification Company conducted re-certification and annual review of the pharmaceutical company's environmental system and quality system respectively.
According to the audit plan, the three teachers of the audit team conducted a comprehensive review of the functional departments of the pharmaceutical company, Jinxi Factory, Qiubin Factory and the plant lifting workshop respectively. Unlike GMP certification, this review is particularly careful about the leadership role, especially in the environmental system, and puts forward different opinions on the application of laws and regulations.
After 4 days of careful review, the review team affirmed the quality work of the pharmaceutical company, and also gave a high evaluation to the environmental monitoring and the operation of facilities and equipment. At the same time, it also put forward requirements for the deficiencies of the pharmaceutical company system. In the end, the audit team believed that the pharmaceutical environmental system met the ISO14001:2015 standard and passed the re-certification. The quality system meets the ISO9001:2015 standard and passes the review.