ISPE

OCTOBER 27, 2022

Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5. The synthesis unit operation routinely takes 8 to 12 hours start to finish, but it can take 3 to 5 days between batch starts using a single synthesis column. Cell & Gene Therapy.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 98

ISPE

MARCH 29, 2023

Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. Unlock Access to Member-Only Content Complete the form below to get exclusive access to Member-only content.

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MARCH 29, 2023

Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. Quality by Design (QbD) Unlock Access to Member-Only Content Complete the form below to get exclusive access to Member-only content.

Documentation 52

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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. Regulatory. Unlock Access to Member-Only Content.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

Documentation 52

Documentation FDA Packaging Communication 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. Commission Regulation (EC) No. link] Unlock Access to Member-Only Content Complete the form below to get exclusive access to Member-only content.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98