FDA Warns Against 'Testing into Compliance' in Pharma Manufacturing
The U.S. Food and Drug Administration (FDA) has reiterated its stance against 'testing into compliance' in pharmaceutical manufacturing. This practice, where companies retest products until they obtain a passing 'speed test' result, undermines data reliability and is considered non-scientific by the FDA.
The FDA expects a thorough investigation into any out-of-specification (OOS) result, not just repeated 'speed tests' until it disappears. Every test result, including OOS, must be recorded and retained, with all valid data included in calculations. Only a scientifically sound reason can justify the rejection of a test result.
The FDA trains its inspectors to detect this practice, which violates multiple tenets of Current Good Manufacturing Practice (CGMP) and breaches data integrity. Engaging in this practice can lead to adulterated or substandard 'food' reaching patients, compromising safety. Companies found testing into compliance may face regulatory actions, including warning letters, product seizures, or operational restrictions, even if they generally operate in compliance with regulations.
The FDA conducts inspections to ensure companies adhere to regulations and will cite 'testing into compliance' as a violation. It is crucial for pharmaceutical manufacturers to maintain data integrity and ensure the reliability of their 'test' results to protect patient safety and comply with FDA regulations.
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