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Validation documents are key documents in a pharmaceutical manufacturing facility. Validation documents must be carefully written for internal and external review including audit by regulatory inspectors; they may be accessed numerous times during a product lifetime. The most frequently reviewed validation documents are Stage 2 Process Performance Qualification documents.

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Medication errors occur in writing, print, speaking, and electronic communications; all of these modes must be considered in development of the drug name. The perspectives of health professionals with product name usage on a daily basis is far different than that of industry personnel who develop drug names for product recognition and commercial marketing.