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Featured Articles

January 2010

The 5 "W"s of Quality Agreements

Items to address in a Quality Agreement include all aspects of a project that affect the identity, quality, safety, potency, and purity of a product. Additionally, include aspects that may affect the compliance status of either the Contractor or Client. One of the most overlooked sections is the Definitions section - it is critical that everyone knows what is meant by every term used in the Quality Agreement; especially when contracting with non-U.S. parties, terminology can vary widely. Include abbreviations and acronyms, and define documents - one person's batch record is another person's data sheet. Define "subcontracting," and if/when it is acceptable. Also, what NOT to exclude from a Quality Agreement is also worth mentioning.

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Things Change - Plan On It

People often bemoan the requirements relating to monitoring and measuring. The general consensus is that it's a good idea to track error and defects, but to monitor that which appears to be running smoothly is a waste of precious resources. Within these tough economic times, that argument can't help but sway managers, unless a compelling counterbalance is offered. Time and again, quality professionals stake their justifications in "ISO says so" rather than in objective indicators.

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Since unavoidable medication risks—mostly represented by gaps in current medical knowledge—cannot be easily addressed by FDA, the agency's Safe Use Initiative focuses on avoidable medication risks which include the generation of erroneous prescriptions, information-related errors on the part of patients, process error due to the mistakes of medical professionals, accidental exposure (to children for example) of medication to individuals unaware of the drugs risk factors, issues of abuse/self-harm and drug defects.
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