Communication Compounding Dosage Magazine 
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.,
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.,
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ISPE
OCTOBER 27, 2022
Broad pipelines require facilities to be designed with a large degree of flexibility to support anything from mild reaction conditions to the use of potent or highly biologically active compounds. You may unsubscribe from these ISPE communications at any time. Cell & Gene Therapy. Unlock Access to Member-Only Content. Company Name.
ISPE
MAY 9, 2023
Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. You may unsubscribe from these ISPE communications at any time.
ISPE
AUGUST 30, 2022
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. The use of structured content and data management in CMC regulatory submissions could potentially provide a direct link to proactively manage risks in the supply chain and communicate with regulators.
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