2004, Documentation, Dosage and Vaccines - Pharmacy Technician Pulse

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2004

Documentation

Dosage

Vaccines

Considerations for a Decentralized Manufacturing Paradigm

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. September 2004. Duplication enables rapid scale-up and scale-out, new facilities can be constructed in less than 12 months, and isolated operation avoids cross-contamination. Journal of Pharmaceutical Sciences 111, no.

Health and Personal Care Stores

Health and Personal Care Stores Vaccines Packaging Documentation

Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

AUGUST 30, 2022

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Additional requirements are described in ICH Q7.

Documentation

Documentation FDA Packaging Communication

Considerations for a Decentralized Manufacturing Paradigm

Regulatory Landscape for Raw Materials: CMC Considerations

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