Communication Dosage Magazine Packaging 
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
MAY 9, 2023
In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.
ISPE
OCTOBER 27, 2022
Oligos generally have excellent stability in aqueous solutions, and lyophilized oligos are dissolved in aqueous formulation buffers for preparation of the final dosage form anyway. You may unsubscribe from these ISPE communications at any time. Cell & Gene Therapy. Unlock Access to Member-Only Content. Company Name.
ISPE
AUGUST 30, 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. You may unsubscribe from these ISPE communications at any time. 5 (May 2022): 1232–1244.
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