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. 2 October 2019. Meet Eli Lilly and Company - 2019 Facility of the Year Process Innovation Category Winner.” 6 November 2019.
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. 8 Wetter, C.,
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ISPE
MARCH 29, 2023
Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. [link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ISPE
MARCH 29, 2023
Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. [link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ISPE
AUGUST 30, 2022
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Published November 2019. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. 9 Lo Surdo, J. Cauchon, C.
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