Compounding Documentation Information Process Improvement 
Impact Pharmaceutical Services
SEPTEMBER 15, 2023
Structure-based drug design has evolved, facilitating the exploration of novel chemical probes and lead compound potency, and molecular docking utilizes target structures to predict interactions and offers simplicity and speed. Downstream optimization targets increased throughput, reduced costs, and improved product quality maintenance.
ISPE
MARCH 29, 2023
Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 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.” The authors propose using Module 2.3 Published 15 November 2021.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
ISPE
MARCH 29, 2023
Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 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.” The authors propose using Module 2.3 Published 15 November 2021.
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. Previous articles have discussed these applications and biopharmaceutical industry examples at greater length and detail. 22 March 2018.
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.
59 
Let's personalize your content