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Toppan Subsidiary Okapi Pharmacy Launches Medicine Delivery Service

Pharma Mirror

The post Toppan Subsidiary Okapi Pharmacy Launches Medicine Delivery Service appeared first on Pharma Mirror Magazine. Todokusuri EXPRESS responds to the needs of the.

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Message from the Chair an Exciting Year

ISPE

Reintroducing the liaison role of International Board members with individual Chapters and Affiliates has given us direct lines of communication to the mutual benefit of the International Board and the local groups. Board members were most impressed by the state-of-the art technology and the use of robots in the processes.

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Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging. You may unsubscribe from these ISPE communications at any time. Getting More from Facilities. Cell & Gene Therapy. Unlock Access to Member-Only Content.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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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CMC Requirements for New Drug Registration in Latin America

ISPE

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.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 7 An integrative (vs. 7 An integrative (vs.