European Pharmaceutical Review

JANUARY 25, 2024

7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 Even in countries with high smartphone usage such as Denmark, up to 25 percent of the population do not possess a smartphone. Article 63 EMA (29 January 2020).

Packaging 98

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

ISPE

MARCH 7, 2023

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

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

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

In a 2009 Pharmaceutical Engineering® magazine article, Mason, McGarvey, and Spearman reported air speed measurements and air flow patterns in conventional cleanrooms with obstacles in the room, which caused obstruction of the unidirectional air flow. 4 (2009): Online Exclusive: [link] 10 US Food and Drug Administration.

Documentation 52

Documentation FDA Packaging Communication 52

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

Packaging 52

Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52