In mid-August, Jinhua Pharmaceutical Company successfully obtained the new version of GSP certification issued by Zhejiang Food and Drug Administration.
From June 28 to 30, a GSP certification team composed of three experts from the Drug Certification Center of Zhejiang Food and Drug Administration conducted an on-site inspection of the new version of GSP certification in pharmaceutical companies. Based on the new version of the "Pharmaceutical Business Quality Management Regulations", the inspection team conducted a comprehensive review of the quality management system documents, computer systems, organizational structures, personnel files, training files, facilities and equipment. Through on-site inspection, verification of relevant original records, access to relevant system data, and on-site questions from relevant personnel, a comprehensive, detailed and objective inspection of the company's quality management system operation was conducted.
Since the implementation of the new version of GSP, the pharmaceutical company has not only revised and improved the quality management system documents, upgraded the computer management system, decomposed the quality policies and objectives and effectively implemented them, organized all staff to carry out the new version of GSP learning and training, specially trained key positions in a targeted manner, evaluated the quality risks of the whole process, and continuously improved the quality management system. The relevant work of the pharmaceutical company to implement the new version of GSP has been fully affirmed by the inspection team. They unanimously believe that the company's staffing meets the requirements, the organization is sound, the quality management system documents are perfect, the management place and storage conditions are suitable for the scale and variety of operation, the computer management system basically meets the requirements of the whole process of operation management and quality testing, and the relevant processes of drug procurement, acceptance, storage, maintenance, sales, transportation and distribution are relatively standardized, in all aspects have reached the new GSP management requirements.
The smooth passage of the new version of GSP marks a new step in the overall quality management of the pharmaceutical company, and also creates the necessary conditions for the company's next stage of development and growth.