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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. Processes 9, no. September 2014. 4 (2014):771–83. 3 (2021):457. doi:10.3390/pr9030457 28 Parenteral Drug Association.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.