GMP CONSULTANT PROVISIONS WILL BE DELETED IN FINAL FDA REGULATION; GMP REG ALSO WILL ELIMINATE REQUIREMENT FOR TESTING OF THREE PRODUCTION BATCHES
This article was originally published in The Gray Sheet
Executive Summary
Provisions that would have required manufacturers to validate and maintain records on consultant qualifications will be deleted in the final rule revising good manufacturing practices (GMP) regulations, according to staffers in the device center's Office of Compliance.
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