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Understanding CAPA and FDA Requirements
The effective investigation of nonconformance using a corrective and preventive action (CAPA) system forms a vital part of any drug- or devicemaker’s continuous improvement strategy. . . .
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Five Factors That Can Take Your Outsourcing from Nightmare to Nirvana
Quality system regulations envision a risk-based approach to outsourcing operations capable of showing that all products and services obtained meet certain minimum requirements. These oversight requirements for managing an outsourced operation follow a logical cycle, from initial selection and use to postmarket feedback. The essential criteria fall into the following categories: Initial supplier selection: It is important to determine if the firm in question is familiar with FDA requirements. For example, sourcing general-use parts or services for eventual use in a medical-grade product from a supplier of non-medical commercial materials could be problematic, as the supplier might not have in place all necessary controls. . . .
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Writing an Effective and Meaningful Audit Observation
Steven Sharf, GMP Concepts, says a good supplier audit is actionable, clearly written and meaningful. It enables the supplier that's audited to develop corrective and preventive action plan and it should make readers feel as if they're there at the site. . . .
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