Conducting an Effective cGMP and Quality Systems Audit

One of the first questions to be asked before conducting an audit is: Why? This fundamental question constructs a premise for the auditor who plans and conducts the audit. Quality and compliance audits have different purposes and the answer to the question of “Why?” will define the scope and the type of the audit. This article is addressed directly to the auditor in an attempt to provide some fundamentals about the process of auditing. [Editor’s note: This is a departure from Contract Pharma’s style manual, but I’ve elected to go along with it o­n the basis of the article’s general tenor. That noted, future contributors should avoid use of the second person (i.e., “you”), as well as the aforementioned “win-win relationship.”.]

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