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. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Yet in 2021, 100 nanomedicines had been marketed.

Process Improvement 71

Process Improvement Packaging Vaccines FDA 71

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

OCTOBER 27, 2022

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Published online (24 May 2022).

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement. 2022) [link] 8 Kendsersky, B., Robinson, G.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement. 2022) [link] 8 Kendsersky, B., Robinson, G.

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.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 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. Jacqueline E.

Documentation 52

Documentation FDA Packaging Communication 52