ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. 24 August 2018. Published 2018. Current Opinion in Chemical Engineering 22 (2018):62–70. 65: Technology Transfer (revised 2022), aims to standardize the approach to technology transfers, which would include conducting risk assessments, process comparisons, and knowledge transfers.

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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

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 January 2018. US Food and Drug Administration.

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Documentation FDA Communication Packaging 52

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MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). Facility electrification has several benefits, as described in such international energy management standards as ISO 50001:2018 EnMS, 26 European S.I. August 2018. 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 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. Published November 2018. IPRP Strategic Vision 2018–2021. link] 3 a b International Federation of Pharmaceutical Manufacturers and Associations.

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