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.

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. Leave this field blank

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Published July 2014. Lo Surdo, J., Cauchon, C.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. Processes 9, no. September 2014. 65: Technology Transfer (revised 2022), aims to standardize the approach to technology transfers, which would include conducting risk assessments, process comparisons, and knowledge transfers. 4 (2014):771–83. Biotechnology Progress 36, no.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). Green Building Council, 2014. 30 July 2014. You may unsubscribe from these ISPE communications at any time. 7 An integrative (vs. Green Manufacturing for the Pharmaceutical Industry.”

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52