Home » FDA Seeking Comment on Burden of cGMP-Related Recordkeeping
FDA Seeking Comment on Burden of cGMP-Related Recordkeeping
May 27, 2011
About 100 drugmakers will need to create up to 25 standard operating procedures (SOPs) for current good manufacturing practices (cGMPs), resulting in a total of 2,500 new records, the FDA predicts in a request for comment on proposed cGMP information collection provisions.
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