ISPE

SEPTEMBER 11, 2023

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.

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ISPE

MARCH 29, 2023

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.

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ISPE

MARCH 29, 2023

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.

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 15, 2023

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.

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ISPE

AUGUST 29, 2022

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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