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

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 15, 2023

Sustainability Tools and Design Processes When promoting of an initiative’s environmental sustainability ES, we should include a more comprehensive context that considers planet (natural capital), people (social capital), and profit (economic capital). However, it can also reduce the environmental burden of a process. Press Room.

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Packaging Labelling Health Compliance Process Improvement 52

ISPE

OCTOBER 27, 2022

As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging. Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5.

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Process Improvement Packaging Compounding Dosage 98

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

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

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). Finally, the DP is packaged in a suitable container to ensure continued quality. You may unsubscribe from these ISPE communications at any time.

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Documentation FDA Packaging Communication 52