ISPE
OCTOBER 1, 2022
Consistent Measurements from Lab-to-Process Improve Production. Consistent Measurements from Lab-to-Process Improve Production. You may unsubscribe from these ISPE communications at any time. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org. Trudy Patterson.
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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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.”
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. You may unsubscribe from these ISPE communications at any time. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org.
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.
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).
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.
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