ISPE

MARCH 29, 2023

Published June 2008. 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.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published June 2008. 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. Leave this field blank

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 10, 2023

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. You may unsubscribe from these ISPE communications at any time. Commission Regulation (EC) No. Leave this field blank Regulatory Adv Manuf QA

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98