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. 1 (2021):48. 6540 (2021):341–42. Pharmaceutical Processing World. 1 (2021):7200. 13 July 2021. October 2022.
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. 2 CRB Group.
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ISPE
AUGUST 30, 2022
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. 5 (September/October 2021). 2021.09.046 2021. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally.
ISPE
MARCH 29, 2023
Published 15 November 2021. The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” The authors propose using Module 2.3 Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.”
ISPE
MARCH 29, 2023
Published 15 November 2021. The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” The authors propose using Module 2.3 Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.”
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