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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 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 Published 15 November 2021.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 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 Published 15 November 2021.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

3 (2022):593–607. October 2022. Blood 140, supplement 1 (2022):10323–24. 5 October 2022. 18 May 2022. Environmental Monitoring for Closed Robotic Workcells Used in Aseptic Processing: Data to Support Advanced Environmental Monitoring Strategies.” 6 (2022):215. 16 February 2022. September 2022.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). Accessed 3 December 2022. 7 November 2022. www.weforum.org/agenda/2022/11/3-ways-healthcare-systems-carbon-footprint/ 5 European Commission. Accessed 3 December 2022. Washington D.C.:

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Trudy Patterson. Cauchon, PhD.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 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. Trudy Patterson.

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An Evaluation of Postapproval CMC Change Timelines

ISPE

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. 1 (January/February 2022). Cauchon, T. Hedberg, M. Braathen Holm, J. Lepore, et al. Toward a Single Global Control Strategy: Industry Study.”