Communication Compounding 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.”
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
ISPE
OCTOBER 27, 2022
Broad pipelines require facilities to be designed with a large degree of flexibility to support anything from mild reaction conditions to the use of potent or highly biologically active compounds. Cone-bottom reaction vessels can provide the turndown required to process a variety of scales and handle different reactions.
ISPE
SEPTEMBER 11, 2023
Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. Nature Communications 12, no. 3 , 27 Advantages POD increases manufacturing flexibility, speed, and consistency. 3 (2020):e2970.
ISPE
AUGUST 30, 2022
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines contain information regarding regulatory requirements for raw materials.
Expert insights. Personalized for you.
52 
Let's personalize your content