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. Published 12 September 2002. link] 11 Beierle, J., Cauchon, T.

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. Published 12 September 2002. link] 11 Beierle, J., Cauchon, T.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. August 2018. 7 An integrative (vs. 646 of 2016.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52