ISPE

MARCH 29, 2023

9 Among other things, the M4Q(R2) EWG is working toward “organizing product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.” Currently, it takes time and/or communications (e.g., information requests) to fully understand the quality data and its significance in an application.”

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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. Common Technical Document [CTD] sections).

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines contain information regarding regulatory requirements for raw materials. The name of each material, where it is used in the process, and information on the quality and control should be provided.

Documentation 52

Documentation FDA 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). linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). You may unsubscribe from these ISPE communications at any time.

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Packaging Labelling Health Compliance Process Improvement 52

ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. 65: Technology Transfer (revised 2022), aims to standardize the approach to technology transfers, which would include conducting risk assessments, process comparisons, and knowledge transfers. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 36 Sterling, J.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 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. Previous publications on this subject provide general information on BoH assessment timelines (e.g., > 24 months).

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Documentation Process Improvement Packaging Pharmaceutical Companies 98

Pharmaceutical Technology

MAY 9, 2023

For Jamaels, whose track record in managing complex operations and delivering process improvements spans GSK Vaccines and one of the world’s largest companies, GE, the technological shift is an exciting development: “I’m passionate about the digital transformation that our industry is going through,” he says.

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Vaccines Process Improvement Communication 52