Quality Assurance Articles

If a process is out of control, an FDA inspector will find it, eventually. Companies that emerge as winners will be those that embrace compliance as a core business practice. Systems models provide strategic competitive advantage.

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Quality should be built into manufacturing systems instead of being imposed as a corrective action.

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Facilitating Client Audits:The Contract Laboratory Perspective
Barbara Carter-Hamm and Gary Vinson

FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.For full article Click here

WHO - EDM

The corporate fantasy where everyone knows all the systems all too often collides with a nightmare reality where all the systems are known by o­nly a few. Any specification or manufacturing change that affects various departments can quickly become a bewildering morass of proposed, actual, and implemented changes – with few connections to actual lots and practices. Draw a line in the CMC "sand" where those changes actually began.

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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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the International Pharmaceutical Excipients Council (IPEC) updated its 1995 Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients to incorporate ISO 9000:2000 requirements.Recently, the Institute of Quality Assurance/ Pharmaceutical Quality Group (IQA/PQG) proposed the pharmaceutical excipients application standard PS 9000:2002, which introduces three levels of increasingly stringent quality system requirements. However, the author argues that the additional set of GMP requirements is not necessary and, in fact,will result o­nly in increased complexity for excipient manufacturers.

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FDA offers new policies to encourage modern manufacturing approaches and automated systems, to simplify postapproval changes, and to avoid problems with sterile products.


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Part 1 of this article discussed the unique properties of the water molecule. It discussed the five basic groups of contaminants found in water, which are particles, dissolved salts, organics, colloids, and bacteria. Part 1 also provided the reader with an understanding of the importance of water supplies in determining the types of contaminants expected in the water. Part 2 of this article describes the processes used to remove contaminants from a water supply, integrating components into a functional system, and the importance of controls and routine periodic water testing.

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