ISPE

MARCH 29, 2023

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. CPP 29 CMA DS reagent identity (S.2.3)

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

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. CPP 29 CMA DS reagent identity (S.2.3)

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” Processes 9, no. September 2014.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52