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One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.
One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.
Processes 9, no. September 2014. 4 (2014):771–83. AI Technology There are multiple potential future applications of AI technology that can support more efficient technology transfer, scale-up, site monitoring, and regulatory submission processes (see Figure 2). 3 (2021):457. PDA Technical Report No. 29 Ligner, E.
linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). Green Building Council, 2014. 30 July 2014. 7 An integrative (vs. Green Manufacturing for the Pharmaceutical Industry.” 7 December 2017. Green Building Council. LEED Core Concepts Guide.
Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Published July 2014. Lo Surdo, J., Cauchon, C.
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