An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.
We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?
A recent flurry of warning letters issued to manufacturers of over-the-counter (OTC) drug and health products has revealed similar deficiencies related to current good manufacturing practice (GMP) and quality management expectations.
Bias can take many forms and is often not easily recognized by an investigator. Sherlock Holmes was keenly aware of bias' potential impacts. Applying more of Holmes’ famous observations and investigative principles can uncover hidden bias and greatly increase an investigator’s chance of finding that elusive definitive root cause.
This two-part article contains a collection of some of the most famous quotes attributed to Holmes that can be applied to microbial root cause analyses (RCAs). Keeping them in mind when conducting your analyses can greatly increase your chances of success in identifying that elusive definitive root cause.
Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.
How can pharma product quality improve? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance.
FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day.
In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the 7 Tools of Quality.
Microbial data deviation investigations are notoriously difficult to perform. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial.
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