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It must be said frankly that the following opinions are the conclusions drawn by the author based on comparative readings, which may not be perfect and are for reference only
.
If colleagues in the pharmaceutical industry have a deeper understanding, they can learn from each other
.
By comparing the quality of documents issued by various provincial bureaus, the author believes that the current quality of documents issued by Liaoning Provincial Bureau is the highest, and will not evade the difficulties and pain points of the industry, and give clear answers
.
The quality of the documents issued by the Beijing Municipal Bureau is also acceptable, but in comparison, the quality of the documents issued by the Liaoning Provincial Bureau is still lower
.
The characteristics of the documents issued by the Liaoning Provincial Bureau are shown in the following table:
Here, in response to the issue of the change of production site that the pharmaceutical industry is currently paying attention to but a lot of distress, let's take a look at the requirements and comparative analysis of the two regulations of the Liaoning Provincial Bureau:
to sum up
Judging from the above content and information, the current situation in which provinces and bureaus are actively issuing documents to cooperate with the implementation of the national bureau's documents also roughly matches the territory of China's pharmaceutical industry
.
At present, the provincial and municipal bureaus that have officially issued documents or entered the implementation stage are mostly in the developed regions of the pharmaceutical industry, or belong to the traditional advantages of the pharmaceutical industry
.
If in the early days of the founding of the People’s Republic of China, the layout and development of various industries were more affected by the national resource allocation and planned economy; then, the development of the pharmaceutical industry now depends more on the flexibility of provincial policies and the active expansion of local enterprises
.
Clouds gather and scattered, things change and stars move
.
It is hoped that the provincial bureaus will closely follow the national policy, learn from the advanced, reflect on the backwardness, and strive for the first in the follow-up work, and provide policy support for the development of enterprises in the province; instead of letting the enterprises of the province fall behind in the era of disputes in the Warring States period due to the lack of reasonable policies
.
About the author: zhulikou431, senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, in aseptic process development and verification, drug R&D and registration, CTD document writing and review, regulatory audit, international certification , International registration, quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields have deep attainments
.
In recent years, he has begun to focus on the analysis of trends in the pharmaceutical macro-field and the risk management of pharmaceutical companies' M&A projects
.