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An essential part of the manufacturing of drug products is the use of water of different degrees of purity. In particular, purified water and WFI are critical when producing sterile pharmaceuticaldrug products. The research is focused on multiple processes, such as cleaning verification and formulation of drug products.
Implementing PAT in (bio)pharmaceuticalmanufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility. Q8(R2) Pharmaceutical Development. European Commission, 2015.
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