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A big show

time:2018-07-24

Huang Bo's first directorial film, entitled "A Big Show", will be released nationwide on August 10th. The film was self guided and played by Huang Bo for the first time. Wang Baoqiang, Shu Qi, Zhang Yixing, Yu Hewei, Wang Xun, Li Qinqin and Li Youlin co-starred in the super lineup during the summer season. Huang Bo, who has always been invincible on IQ and EQ, appears as a director for the first time. I believe everyone is full of expectations.


But Huang Bo made his debut as a singer in his early years. He was dedicated on becoming a good singer, but the results are not satisfying, just like fists on cotton. After switching job as an actor, everything began to go very smoothly, from "Getting on the Bus and Going on", to "the crazy black skin of Qingdao," which was once a box-office guarantee.


From a mediocre performance as a singer to the rise of his reputation as an actor, Huang Bo's own summary is that he has finally used "power" in the right place, rather than on cotton.


Not only does the performance circle, bu also the development of large-to-national enterprises, small-to-team and personal growth all need accurate focus to prevent detours or pitfalls.


As a result, Editor couldn't help lamenting that the reported incident of suspected data fraud of vaccine was more intense than the typhoon "Ambi" which had just landed, and that the parties concerned had made improper efforts and was absolutely not " a good play."


This incident will not be repeated, readers who have interest in it can check relevant articles. Editor and the general public need to stabilize the mood, and then think about how to solve such incidents from the source, better than uttered words.


The current technology of traditional vaccines is generally established decades ago, at that time with paper records, which could be replaced at will. This is the objective loophole as the manufacturers fabricate production records and test records in the vaccine incident.


How can we put an end to the occurrence of data fraud such as production record and inspection record fabrication? The author specially consulted the experts of the biopharmaceutical industry and the co-workers responsible for data verification in Hanbon. They agreed that the implementation of the computerized system instead of the traditional paper-based recording mode, the electronic signature and the electronic record should be incorporated into the production specification, which would greatly improve the difficulty of data fraud. The enterprise should focus much attention on “Data integrity and audit trail” instead of the effort to tamper with the data.


That is because any national drug-monitoring authorities show zero tolerance for data-related issues of pharmaceutical enterprises .


Organizations of national drug control agencies, led by Europe and the United States, have also issued related regulations for data integrity and computerized verification system . CFDA also implemented the GMP appendix "Computerized System" in 2015, and in October 2016, August 2017 and January 2018 respectively, three revisions were made and issued as the Drug Data Management Standard (draft for comments), which shows the firm determination of CFDA in rectifying and standardizing the pharmaceutical industry. Real data is the basis of all science, whether paper or electronic, and computerized system is a very important part to ensure data integrity.


What is data integrity?

FDA Data Integrity and Compliance With CGMP Guidance for Industry 2016 states that data integrity refers to completeness, consistency, and accuracy of data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or true and valid copies, and accurate(ALCOA).


What is audit tracking?

An audit tracking (CFDA) is a series of record of events related to computer operating system, Apps, and user operations to help track from raw data to related records, reports or events, or from records, reports and events to data.


What is User Rights Management?

To ensure that the personnel only have the operation authority equivalent to the completion of their work duties, the enterprise must establish the login level given to the individual by the SOP certificate to ensure that the historical information about the user's entry level can be obtained, and unique username and password pairs, multilevel permissions and other appropriate management strategies are adopted.


  CASE

In providing services to biomedical companies such as vaccines, Hanbon is often asked about data integrity and audit tracking related questions. In the past few years, some enterprises have paid close attention to the issue of bribery. In recent years, there have been fewer and fewer problems related, which shows that the attitude of the state towards such problems and the degree of supervision have been strengthened. Meanwhile, the awareness of pharmaceutical companies is also constantly increasing. For the general public to eliminate data fraud or counterfeit drugs is only a short-term problem.


The author kept thinking about the problem and couldn't sleep all night so that consulted the director of biological macromolecular division, hoping to have specific examples for proof, to avoid meaningless talk, in order to offer public some information.


Case1:

The unknown impurities in the official release data of a product were reported to meet the quality standard, but the HPLC data showed that the unknown impurities in the batch with injection data did not meet the quality standard. The HPLC impurity data for a batch of stability tests only include the best results from multiple tests, while other results are found in the equipment database, which cannot be found if only the paper version is used.


Case2:

An enterprise modifies the working time of the computer and deliberately advances or pushes back the recording time of production; Supplement the experimental record, which is inconsistent with the actual purification time with the equipment; If a system consistent with electronic signatures and records is used, these modifications will be detected.



Hanbon bio-pro automatic chromatography system and ultrafiltration system which are based on related requirements of ASME BPE and GMP for integrated module design, can provide users with related validation documents and services required by regulations of GMP.

In addition, the system control software adopts the GE or SIEMENS configuration software mode and meets the requirements of FDA 21CFR Part11. The system software has a complete set of mechanisms to ensure the integrity, reliability and accuracy of data in the process of storage, backup, migration and recovery.

Jiangsu Hanbon Sci-tech Co.Ltd can provide users with independent computer system verification documents.

Vaccines are essential to the health and safety of everyone, and the conscience of those in the pharmaceutical industry is important. However, if we can make counterfeiting technically impossible, that will be the fundamental solution to this kind of counterfeiting.

Both A Big Show staged by Huang Bo and the medical incident are inspirations to us. The successful cases are not easy to be copied, but the lessons of failure can be easily bypassed.