ISPE

SEPTEMBER 11, 2023

3 (2020):e2970. Nature Communications 12, no. 16 June 2020. Organic Process Research and Development 24, no. 10 (2020):1861–75. Pharmaceutical Engineering September/October 2020. 8 June 2020. Biotechnology Progress 36, no. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 13 July 2021. Fierce Pharma.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

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

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Documentation FDA Communication Packaging 52

ISPE

MARCH 29, 2023

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.,

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

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.,

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

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.

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Documentation FDA Packaging Communication 52

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. Scope The scope of the assessment was for country approvals received in the calendar years 2018–2020. Published March 2020. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

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Pharmaceutical Technology

MAY 9, 2023

According to GlobalData analysis, the number of clinical trials with a decentralised and virtual component increased by 50% between 2020 and 2021, and this trend is here to stay. The Covid-19 pandemic catalysed an enormous upswing in the adoption of innovations including telemedicine, wearables and remote patient monitoring.

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Vaccines Process Improvement Communication 52