Communication Dosage Information Process Improvement 
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
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
SEPTEMBER 11, 2023
POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Nature Communications 12, no. Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.”
ISPE
OCTOBER 27, 2022
Oligos generally have excellent stability in aqueous solutions, and lyophilized oligos are dissolved in aqueous formulation buffers for preparation of the final dosage form anyway. Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5.
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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