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FDAnews Drug Daily Bulletin
Oct. 9, 2012 | Vol. 9 No. 198
Quality Control Checklists Can Inhibit Inspections, Close Minds
Drugmakers’ quality control checklists make it difficult for inspectors to interpret manufacturing failures and foster a true understanding of mistakes, regulators and industry officials say. “Check-the-box approaches have the advantage of promoting a degree of quality consistency, but they close down the mind to a bigger picture,” Ian Thrussell, head of inspections at the World Health Organization and an expert inspector with the UK’s Medicines and Healthcare products Regulatory Agency, said.
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