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A Proposal for a Comprehensive Quality Overall Summary

ISPE

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. For purpose of illustration used throughout this article, labels have been assigned to each CQA. The summary included the concepts outlined in this article and aimed to clearly convey the product control strategy. McMahon, R.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. For purpose of illustration used throughout this article, labels have been assigned to each CQA. The summary included the concepts outlined in this article and aimed to clearly convey the product control strategy. McMahon, R.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

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. Journal of Pharmaceutical Sciences 109 (2020):1427–1438.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). This article highlights the regulatory expectations of raw materials, the challenges of postapproval changes. October 2020. 16 October 2020. Burke, S., Hammond, and T.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. 3 (2020):e2970. 16 June 2020. 10 (2020):1861–75.

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An Evaluation of Postapproval CMC Change Timelines

ISPE

These long global approval timelines complicate supply chain management by delaying innovations that improve quality assurance and by increasing the potential for supply interruptions and shortages that impact patient access to products. Scope The scope of the assessment was for country approvals received in the calendar years 2018–2020.