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On September 4, the State Drug Administration held a summary meeting on the internal audit of the quality management system for vaccine supervision, summarized the internal audit of the quality management system for vaccine supervision, and deployed the next stage of the construction of the quality management system for vaccine supervision.
, a member of the Party Group of the State Drug Administration and deputy director of the State Drug Administration, attended the meeting and spoke.
internal audit is an important part of the construction of the quality management system of vaccine supervision, and it is the main method and measure to evaluate the effectiveness of the quality management system and continuously improve the quality management system.
The State Drug Administration on July 20 deployed to carry out the quality management system of vaccine supervision internal audit work, the use of written audit, audit outline question and answer and on-site inspection documents, audit the State Drug Administration vaccine supervision work process, audit time of one week.
fully recognize the results of the internal audit process.
Through internal audit, the concept of quality management of vaccine supervision has been further enhanced and more deeply integrated into the daily supervision and business work, the team of internal auditors has been effectively trained to form an internal audit working mechanism, and accumulated experience in order to promote the in-depth development of supervision and quality management work;
national regulatory system (NRA) to assess the maturity level of the national regulatory system sector from level 2 to level 3, which provides a good basis for meeting the World Health Organization vaccine NRA assessment.
meeting stressed that the operation and maintenance of the quality management system for vaccine regulation is a long-term dynamic process that needs to be sustained.
to establish and continuously improve the quality management system is not only the need for vaccine NRA evaluation, but also the need to improve the level of regulatory standardization.
we should attach great importance to the rectification of internal audit problems, carefully analyze the reasons, put forward practical measures to solve them, and further establish a sound and effective operation of the quality management system.
meeting called for quality management to be integrated into the actual work of vaccine supervision, through the effective operation of the quality management system, to promote compliance with the regulatory work.
, but also through regulatory practices, continuous improvement of the quality management system.
The departments of the State Drug Administration and the vaccine NRA evaluate the various sectors to take the initiative, actively cooperate, in the system construction, system construction and operational work to do a good job of convergence, orderly promote the next phase of vaccine supervision quality management system work.
relevant departments of the State Drug Administration are mainly responsible for comrades and related personnel, vaccine supervision and quality management system construction office personnel and internal auditors to attend the meeting.
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