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

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. 24 August 2018. Published 2018. Current Opinion in Chemical Engineering 22 (2018):62–70. EMA/CHMP/BWP/187162/2018.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52