Tag: GMP deviations

How to Address Cross-Contamination Risks Using GMP Risk Management Addressing Cross-Contamination Risks with GMP Risk Management Introduction Cross-contamination is one of the most critical risks in pharmaceutical manufacturing, posing a significant threat to product quality and patient safety. Good Manufacturing Practices (GMP) provide a robust framework for preventing cross-contamination by enforcing stringent controls and guidelines….

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How to Integrate Risk Management with GMP Validation and Qualification Integrating Risk Management with GMP Validation and Qualification Introduction In pharmaceutical manufacturing, Good Manufacturing Practices (GMP) validation and qualification are critical processes to ensure that systems, equipment, and processes consistently produce products meeting predefined quality standards. However, these activities often involve complexities and potential risks…

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