Make GMP quality system "intelligent" through applying informatization thereto

Since founded in Singapore in 2004, Soltoris Lifescience Management Consultants has been committed to helping customers improve quality management systems to comply with GMP requirements, and over 14 years of development, has established good cooperation with numerous famous pharmaceutical enterprises in the North America, Europe, and Asia, including Pfizer, Roche, GSK, Novartis, Lonza, Abbott, and MSD, etc. After formally entering the Chinese market in 2012, it has launched the first information-based solution for GMP quality management on the Chinese market that complies with Chinese and overseas GMP data reliability specifications: SISQP + GMP Comprehensive Quality Management System, besides successfully helping more than a dozen Chinese pharmaceutical enterprises pass the European and American GMP certification. This system has been successfully implemented and launched in more than 20 famous Chinese enterprises. Soltoris hopes to construct compliant, efficient, and controllable quality management systems for customers to improve quality management levels through the more advanced and more rigorous information-based management mode.

Editor: What changes and upgrades do you think the pharmaceutical industry will be confronted after the proposing of Made in China 2025 and Industry 4.0?

Soltoris: The Guiding Opinions on Advancing the Construction of Important Product Information Traceability Systems (the "Guiding Opinions") issued by the CFDA on February 23, 2017 proposes "Promote pharmaceutical production and circulation enterprises to implement the entity responsibilities, and to acquire and preserve information such as source of raw material, production process, and purchase and sale records, etc. through information technology and according to laws and regulations and the Chinese standards, to guarantee the traceability of pharmaceutical products. Expand the coverage of pharmaceutical product tracing regulation, and gradually achieve the fast tracing of all the pharmaceutical products in the whole course from production, circulation, to use. Establish the pharmaceutical product tracing management mechanisms".

Compared to non-mandatory industry trends such as Made in China 2025 and Industry 4.0, the Guiding Opinions, if coming into force, will raise the importance of the informatization to the level of mandatory regulation of China, which normalizes pharmaceutical enterprises to implement the pharmaceutical product tracing management mechanism through information technology.

The information construction of the pharmaceutical industry is relatively backward, compared to other manufacturing industries. However, as the Guiding Opinions comes into force, all pharmaceutical enterprises will be compelled to carry out the information-based management, and some backward pharmaceutical enterprises which fail to follow up the information construction trend will be eliminated, to thus promote the whole industry to accelerate upgrading.

Editor: According to information, Soltoris has good cooperation with many Chinese enterprises. How do you think the Chinese pharmaceutical enterprises should work out own 4.0?

Soltoris: Pharmaceutical enterprises must have clear thought and planning for intelligent manufacturing or Industry 4.0, instead of being dominated by suppliers. Hardware and software are only tool, instead of cure-all. Even with the best tools, if there are no personnel with high quality to use and operate them, or the system fails to meet GMP compliance requirements, all will be in vain. Furthermore, hardware and software are not necessarily good when they are high-end, magnificent and classy, but shall be adapted to pharmaceutical enterprises’ own requirements. Appropriate hardware and software, and appropriate functions of hardware and software shall be selected for the implementation, to ensure satisfaction of enterprises’ business needs and regulation compliance requirements. There is never the solution that settles everything at one go, or the implementation shortcut that leads to success in one step.

Editor: Could you give pharmaceutical enterprises some suggestions for what they should do at present to walk on the automation and informatization path in the future?

Soltoris: The followings are my personal viewpoints:

1)    Deeply think the "objective and strategy of implementing automation and informatization"

2)    Strengthen the understanding and practice of GMP compliance

3)    Pay attention to data integrity

4)    Pay attention to computer system verification

5)    Select qualified software providers and system integrators, to make sure that the system finally implemented is compliant

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