Pharma Articles

Global medicine regulatory bodies are organizations responsible for regulating medicinal products, including pharmaceuticals and medical devices, in different countries or regions around the world. These regulatory bodies establish standards and guidelines for developing, testing, and marketing medicinal products to ensure their safety, efficacy, and quality. Global medicine regulatory bodies play a crucial role in ensuring …

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9 Useful Website for Patient Education BeMedWise Through online education programmes, promotes safe and proper medication usage. bemedwise.org ConsumerMedSafety A public service website aiming to assist customers in avoiding medication errors. consumermedsafety.org NPS MedicineWise Consumer health information and health professional education nps.org.au Safe Medication Patient education material and in-depth drug information database from AHSP (American …

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There are 13 online resources that give medication reference information centerwatch.com This medication reference provides both professionals and patients about clinical trials. dailymed.nlm.nih.gov This medication reference is the official source for current FDA label information and package inserts in the United States. drugbank.com This medication reference is a comprehensive online drug data library that includes …

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Preparation for Regulatory Inspections with answers to potential issues Introduction A regulatory audit always requires a lot of last-minute planning. During this period, new issues emerge while old ones resurface. The observed issue might be Critical, major, or minor. Some are under process, partially rectified, or left untouched for several reasons.  When the inspection is …

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The impact of packing material on the stability of pharmaceutical products General Overview What is the packaging? Packaging is described as the collection of various components surrounding a pharmaceutical product from the moment it is manufactured until it is used. The significance of packaging (1) Guards against all extraneous influences that could affect the product’s …

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Why is 70% IPA such a popular disinfectant? General information about Isopropyl Alcohol (IPA) IPA is a type of alcohol that is a transparent, colorless, mobile, volatile, flammable liquid having a strong odor. Image:  Synonyms: IPA are 2-propanol, and Isopropanol, isopropanol, sec-Propyl alcohol, IPA, Isopropanol, Isopropyl alcohol Linear Formula: (CH3)2CHOH CAS Number: 67-63-0 Molecular Weight: 60.10 …

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Standard Operating Procedure for Analysis and Release of Packaging Materials Standard Operating Procedure for Analysis and Release of Packaging Materials 1. Purpose: To lay down a procedure for Analysis and Release of Packaging Materials. 2. Scope: The scope of this is applicable document is to provide the procedure for Analysis and Release of Packaging Materials …

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Standard Operating Procedure for Analysis and Release of Raw Materials Standard Operating Procedure for Analysis and Release of Raw Materials 1. Purpose: To lay down a procedure for Analysis and Release of Raw Materials. 2. Scope: The scope of this is applicable document is to provide the procedure for Analysis and Release of Raw Materials …

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Basics of Nitrosamine Impurities Quality Risk Management Background Nitrosamine Impurities: Authorities in the EU discovered a nitrosamine impurity, N-nitrosodimethylamine (NDMA), in valsartan from one manufacturer of active pharmaceutical ingredient (API) in June 2018. N-nitrosodiethylamine (NDEA), another nitrosamine, was later discovered. The FDA discovered that three popular heartburn medications (ranitidine, also known as Zantac, and nizatidine, …

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