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Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?
The biopharmaceutical industry has undergone major changes since GMPs were last updated in 1977. However, FDA says it has no plans for any major revisions of cGMPs. Industry experts argue, however, that changes are needed in Training and employee personal development, statistics and sampling, and process validation.
eBook: Regulatory Sourcebook, September 2019
When referring to this article, please cite it as A. Shanley, “Is it Time to Update cGMPs?" BioPharm International Regulatory Sourcebook eBook (September 2019).