Quality assurance unit 3.pdf

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The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise boosts blood flow and levels of serotonin and endorphins which elevate mood and may help prevent mental illness.

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The ICH guidelines for stability testing define what information must be provided at the time of applying to register a new drug molecule. These guidelines were first adopted in 1993. After revision and updation, the current version in use called Q1A(R2) has been adopted since 2003. This guideline harmonizes the drug registration process for all drugs in the USA, Japan, and the EU. This means a drug registered in one of these regions will not require repeated stability testing when to be sold in any of the other two regions. Stability testing is important because drug products must be stable when administered to patients. If an unstable product degrades into toxic metabolites, or if the activity of the drug reduces below 85% of the label claim, there can be serious therapy failures that may even result in death. Stability testing also provides data to choose the formulation parameters, excipients, and the right container-closure system to ensure safe and effective quality products that retain activity throughout the shelf life.

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