Hikma Farmaceutica, (Portugal) S.A. Warning letter (October 2014) 1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm failed to conduct thorough investigations of your environmental monitoring (EM) excursions Your firm also failed to implement corrections to address possible contributing factors for the isolates recovered during environmental monitoring (EM) 2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
Posted on: Sun, 09 Nov 2014 16:19:30 +0000
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