Supplier Management and Auditing

REQUIREMENTS ICH Q10 Pharmaceutical Quality System , Section G provides guidance on the Management of Outsourced Activities and Purchased Materials. “Pharmaceutical companies are responsible for ensuring processes are in place to assure the control of outsourced activities and quality of purchased materials.” HOW? Assess PRIOR to outsourcing operations or selecting material suppliers the suitability and…

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N95 Mask Sampling Requirements

NIOSH 42 CFR Part 84 provides the standards for the approval of N95 respiratory protective devices. The approval of N95 respiratory protective devices requires that there be a Quality Control Plan in place. Part 84.41 describes the Quality Control Plan.  One of the parts of the Quality Control Plan which must be in place in…

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Metrics, the Foundation and Emotions

Metric Reporting

Metrics, This one word can cause many emotions, fear, trembling, excitement, or dread! I have experienced all of these emotions when it comes to metrics. That Pareto Chart ascending or descending in at a particular elevation or curve can have a profound effect upon us! The FDA has recognized the importance of Quality Management System…

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