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. Common Technical Document [CTD] sections).

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European Pharmaceutical Review

JANUARY 27, 2025

The inevitable shift to external manufacturing sites necessitates a seamless technology transfer process, and should incorporate unique perspectives on local approaches to knowledge transfer, quality, regulatory and all other operational requirements pertaining to the sites locality.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

Although the novelty of these modes of manufacturing has led to some definitional ambiguities, initial working definitions and terminology have been drafted by several regulators, trade organizations, and subject matter experts. These new operating models can help enable and accelerate the efforts of Pharma 4.0™ 22 March 2018.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 21 , 22 In this context, the term recycle has a few definitions. 7 An integrative (vs. Recycling programs for spent single-use consumables include partnerships such as MilliporeSigma/Triumvirate.

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Packaging Labelling Health Compliance Process Improvement 52