ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Nature Communications 12, no. 24 August 2018. Published 2018. Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” Biotechnology Progress 36, no. 3 (2020):e2970.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

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.,

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

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.,

Documentation 52

Documentation Dosage Packaging Communication 52