European Pharmaceutical Review

FEBRUARY 12, 2024

These innovative technologies include highly automated, fully digitalised process analytics technologies (PAT) , as well as automated and robotic testing technologies to confirm product quality. The complex and intricate processes involved in upstream and downstream manufacturing are highly refined, he notes.

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Process Improvement Packaging 91

ISPE

SEPTEMBER 11, 2023

24 August 2018. Published 2018. Current Opinion in Chemical Engineering 22 (2018):62–70. EMA/CHMP/BWP/187162/2018. 22 March 2018. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2018. “Eli Lilly’s Award Winning Project Is Extended with an Additional Module.” 6 November 2019.

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

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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). 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.

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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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Documentation Process Improvement Packaging Pharmaceutical Companies 98

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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