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Ion Program United States Pharmacopeia 12601 Twinbrook Parkway, Rockville MD 20852 Updated: April 1, 2008 Created by: Joyce Primo-Carpenter, M.D., BSc. Pharm. USP DQI Associate Director, 2003-2008 This publication was made possible through support provided by the U.S. Agency for International Development, under the terms of Cooperative Agreement number HRN-A-00-00-00017-00. The opinions expressed herein are those of the author(s) and do not necessarily reflect the views of the U.S. Agency for.
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Usp FAQ
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QA in the pharmaceutical industry involves implementing systems and processes to ensure that products consistently meet or exceed established quality standards. It encompasses activities such as Good Manufacturing Practices (GMP), quality management systems, and adherence to regulatory requirements.
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The fallout of falsified and substandard medicines includes poisoning, untreated disease, early death, and treatment failure.
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Pharma QA and a sound quality assurance department are the backbones of the pharmaceutical business. They allow companies to guarantee that their products conform to applicable quality, drug stability and safety standards. In addition, they ensure that a company avoids non-compliance of regulatory requirements.
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Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications.
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There are two main categories of poor-quality medicines: substandard and counterfeit (Box 1). Substandard products arise as a result of lack of expertise, poor manufacturing practices, or insufficient infrastructure, whereas counterfeits are the 'products' of criminals [1,2].
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The consequences of poor medicine quality include: prolonged sickness, treatment failure, side effects, loss of income, emergence of drug resistance, increased healthcare costs, and death.
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Falsified and substandard drugs may contain toxic doses of dangerous ingredients and cause mass poisoning. Poor-quality medicines compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance, and death.
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If you don't take your medication as prescribed by your doctor or pharmacist, you won't have the right amount of medicine in your body at the right time to manage your condition. It could lead to your condition getting worse, hospitalization or yes, even death.
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