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. Common Technical Document [CTD] sections).

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021. If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published 15 November 2021. If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3

Documentation 52

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ISPE

SEPTEMBER 11, 2023

1 (2021):48. 6540 (2021):341–42. Pharmaceutical Processing World. 1 (2021):7200. 13 July 2021. Updated 22 July 2021. 2021, Washington, D.C.: Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” 3 a b c Algorri, M., 3 (2022):593–607. October 2022.

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ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 14–25 (November–December 2021). 25 February 2021. BioProcess International 8 December 2021 (November–December 2021) [link] 23 Bio-Process Systems Alliance. 14 Whitford, W.

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ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

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ISPE

SEPTEMBER 10, 2023

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. Published 2021. IPRP Strategic Vision 2018–2021. WHO Expert Committee on Specifications for Pharmaceutical Preparations.” Accessed 14 June 2023.

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