Pharmaceutical Technology
JUNE 19, 2023
It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live. Products are stored and packaged in a dedicated suite by a dedicated team,” explains MacNeir. The requirements When handling personalised medicines, time is of the essence.
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.
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The FDA Law Blog
JULY 10, 2023
FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.
ISPE
MAY 11, 2023
defines a service-oriented architecture (SOA) where application components provide services to the other components through a communication protocol over a network. The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. to Industry 4.0 2 3 a b Hankel, M.,
European Pharmaceutical Review
OCTOBER 5, 2022
For most consumers, product packaging represents their first impression of a brand and its sustainability credentials. But how is this push shaping the pharma packaging market and what are the key changes we can expect to see? For many, aesthetic appeal and user experience top the list of priorities when it comes to packaging design.
pharmaphorum
APRIL 11, 2022
Data will always be central to everything we do, as it has the power to communicate the potential of a new treatment to change a person’s life. Between 2016-2019, she was the medical affairs therapeutic area lead in haematology for Janssen Oncology across the EMEA region.
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.
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