Compounding Documentation 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. Both processes are evolving to enhance product development and output.
ISPE
MARCH 29, 2023
Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.
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ISPE
MARCH 29, 2023
Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. 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. en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf 66 a b DitaExchange. 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. Health authorities have divergent classifications for changes in terms of risk to product quality and documentation/data requirements. Burke, PhD. 1 September 2022.
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