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). 2 October 2019. 11 September 2019. 6 November 2019. 12 July 2019.

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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). 24 September 2019. 7 An integrative (vs. 7 An integrative (vs. 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

MARCH 29, 2023

Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. [link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 52

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MARCH 29, 2023

Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. [link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Dosage Packaging Communication 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. ChromaCon 2019. Some regulatory hurdles remain around classification of solution phase oligo as API versus drug product intermediates. 8 Wetter, C.,

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Process Improvement Packaging Compounding Dosage 98

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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. Published November 2019. Published November 2019.

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Documentation FDA Communication Packaging 52

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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. Published November 2019. 9 Lo Surdo, J. Cauchon, C. Ramdas, and E. Zavialov. “A

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Documentation FDA Packaging Communication 52