pharmaphorum

NOVEMBER 16, 2020

In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”.

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Vaccines Packaging FDA 64

European Pharmaceutical Review

MARCH 1, 2023

Nowhere is this more publicly evident than in the development, regulatory approval, and efficacious use of mRNA‑based vaccines for COVID-19. Beyond the high-profile COVID-19 vaccines, mRNA therapeutics are crucial in applications such as protein replacement therapies and regenerative medicine. 2014 Nov 20; 56(4), 506‑17.

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ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 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). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 29, 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. Published July 2014. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52