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2024年4月13日发(作者：python少儿编程课程体系)
药品生产工艺流程控制方法
英文回答：
Pharmaceutical Production Process Controls.
The pharmaceutical industry is heavily regulated to
ensure the safety and efficacy of its products. This
includes strict controls over the manufacturing process,
from the sourcing of raw materials to the packaging and
distribution of finished products.
Process Control Methods.
There are a number of process control methods that can
be used in pharmaceutical manufacturing. These include:
Statistical process control (SPC): SPC is a
statistical method used to monitor and control the
manufacturing process. It involves collecting data on key
process parameters and using statistical techniques to
identify and correct any deviations from target values.
Process analytical technology (PAT): PAT is a system
that uses online sensors and other analytical tools to
monitor and control the manufacturing process. PAT can be
used to identify and correct deviations from target values
in real time.
Quality by design (QbD): QbD is a pharmaceutical
development approach that focuses on designing and
controlling the manufacturing process to ensure the desired
product quality. QbD involves identifying the critical
process parameters that affect product quality and
developing a control strategy to manage these parameters.
Benefits of Process Controls.
Process controls can provide a number of benefits,
including:
Improved product quality: Process controls can help to
ensure that pharmaceutical products meet their intended
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