—Hongqi Pharmaceutical "Second Quality Management Month" Activity Series 2
On July 1, 2020, the State Drug Administration issued an announcement, in order to implement the relevant provisions of the Drug Administration Law and the Vaccine Administration Law, strengthen the record and data management of drug development, production, operation, and use activities to ensure that the relevant information is true , Accuracy, completeness and traceability, and formulated the "Drug Record and Data Management Requirements (Trial)", which will be implemented from December 1, 2020.
As one of a series of regulations issued by the State Food and Drug Administration, the "Pharmaceutical Data Management Practices" has been solicited for the first time since 2016. After 4 years of arduous solicitation, discussion and revision, it was finally renamed as "Drugs" on February 28, 2020. The "Regulations for Records and Data Management", again solicited comments, and officially released on July 1st, is enough to show the State Drug Administration's cautiousness and attention to the reliability of data. The history of legislation is as follows:
The first consultation on October 10, 2016-"Pharmaceutical Data Management Standards (Draft for Solicitation of Comments)"
The second consultation on August 25, 2017-"Pharmaceutical Data Management Standards (Draft for Solicitation of Comments)"
The third consultation on January 5, 2018-"Pharmaceutical Data Management Standards (Draft for Solicitation of Comments)"
The fourth consultation on February 28, 2020-"Guidelines for the Management of Drug Records and Data (Draft for Solicitation of Comments)"
Officially released on July 1, 2020-"Drug Record and Data Management Requirements (Trial)"
The issuance of national regulations is a mandatory standard in the industry. The regulations issued this time not only have requirements for paper records, but also emphasize the requirements for electronic records and data, which are also in compliance with the increasing use in the pharmaceutical industry. The current state of computerized systems. In recent years, the inspection of data reliability has also been the focus of inspections in various inspections conducted by the State Drug Administration and Liaoning Provincial Drug Administration.
For us, the most important thing is to implement the requirements of laws and regulations into our actual management and implementation process. In order to accurately and effectively implement the requirements of regulations, the Quality Assurance Department deliberately arranged the content of the interpretation of regulations and gap analysis during the second quality activity month, not only in accordance with the requirements of the regulations, but also in reference to the "Data Reliability" issued by Fosun Pharma Group. "Guide", find our own weaknesses and shortcomings, target ourselves from within us, complete gap analysis, and promote the improvement and improvement of data reliability. In the next step, the Quality Assurance Department will organize relevant departments to compare our gaps, formulate corrective and preventive measures, and make continuous improvements. While meeting compliance requirements, we will continue to improve our level of awareness and management.