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This title is actually for grandstandi.
*: The European Community and the Ministry of Health have changed their names several times, reflecting their names at that ti.
After 60 years of ups and downs, the formation of any regulations often stems from painful lesso.
In the second stage, ICH issued relevant guidelines ~ Q8 on drug development and Q9 on quality risk management, that is, the concept of QbD and quality risk and data integrity (currently translated into data reliability, due to the name and the popularity of the peop.
2 principles of quality risk management:
· The assessment of quality risk should be based on scientific knowledge and fundamentally linked to patient/consumer protection; · The extent, format, and documentation of the risk management process should be appropriate to the level of risk
So far, the GMP fortress has been completed, a system with direction, engines and boundaries, and self-optimization capabilities (continuous improvement in quality management, life cycle concept, e.
The slimming method of lean producti.
The slimming approach to lean producti.
A team-based approach to stakeholder manageme.
Technology-respected focused pl.
It seems that lean production, related party management, and technical improvement are related but not related to G.
This reminds me of what Zhang Mazi said to Huang Shilang in "Let the Bullets Fly": "You are not important to me, without you, yes I'm very important", also for regulators, "I don't care about running GMP, without GMP, I'm very concern.
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