European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Significance of Annex 1–2022 for implementing Pharma 4.0 Significance of Annex 1–2022 for implementing Pharma 4.0 Tanzini et al.

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Process Improvement Packaging Vaccines FDA 95

ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Trudy Patterson.

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Process Improvement Packaging Compounding Dosage 98

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). Accessed 3 December 2022. 7 November 2022. Accessed 3 December 2022.

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Packaging Labelling Health Compliance Process Improvement 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). 3 (2022):593–607. October 2022. Blood 140, supplement 1 (2022):10323–24.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). raw materials, intermediates, DS, formulation, and packaging components, DP—against pre-defined specification criteria to confirm control.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). raw materials, intermediates, DS, formulation, and packaging components, DP—against pre-defined specification criteria to confirm control.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 29, 2022

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Trudy Patterson. Cauchon, PhD.

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