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Consistent Measurements from Lab-to-Process Improve Production

ISPE

Consistent Measurements from Lab-to-Process Improve Production. Consistent Measurements from Lab-to-Process Improve Production. You may unsubscribe from these ISPE communications at any time. Trudy Patterson. Sat, 10/01/2022 - 06:00. Sponsored Content. 1 October 2022. Leave this field blank.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Nature Communications 12, no. 65: Technology Transfer (revised 2022), aims to standardize the approach to technology transfers, which would include conducting risk assessments, process comparisons, and knowledge transfers. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 36 Sterling, J.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5. You may unsubscribe from these ISPE communications at any time. Cycling through columns can drastically increase synthesis output. Leave this field blank.

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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. You may unsubscribe from these ISPE communications at any time.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.