Aseptic Processing of Biological Products: Regulatory Issues (5of6) Microbiology – Mar. 15, 2017

Candace Gomez-Broughton from CDER’s Office of Pharmaceutical Quality discusses quality microbiology content of CDER biologics license applications submissions and guidance documents and regulations. She also covers process validation common deficiencies such as sterilizing filtration, post-reconstitution and post-dilution storage, container closure integrity, and drug product quality micro content for BLAs.
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