European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Continuous manufacturing in the biopharmaceutical industry guarantees high quality and high process efficiency. Tanzini et al.

Process Improvement 95

Process Improvement Packaging Vaccines FDA 95

ISPE

OCTOBER 27, 2022

As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging. Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 98

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.” information requests) to fully understand the quality data and its significance in an application.” Currently, it takes time and/or communications (e.g.,

Documentation 52

Documentation Dosage Packaging Communication 52

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.” information requests) to fully understand the quality data and its significance in an application.” 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. Common Technical Document [CTD] sections).

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

MARCH 15, 2023

Sustainability Tools and Design Processes When promoting of an initiative’s environmental sustainability ES, we should include a more comprehensive context that considers planet (natural capital), people (social capital), and profit (economic capital). However, it can also reduce the environmental burden of a process.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. This is followed by DP manufacturing, where the DS is formulated with excipients. Control of Materials.

Documentation 52

Documentation FDA Packaging Communication 52