Once Again, Lack of SOP Compliance Tops List of 483 Observations - BioProcess Blog | The Health, Drug, Prescription, and GMP Supersite

BioProcess Blog » Blog Archive » Once Again, Lack of SOP Compliance Tops List of 483 Observations:

"Top of the FDA list, at 155 of the 690 citations (22%) was the observation that “The responsibilities and procedures applicable to the quality control unit are not in writing or not fully followed.” This finding emphasizes the importance that the regulatory agencies have always placed on the need for companies to have strong quality management systems."

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