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Good Manufacturing Practices for Sterile Products (Injections, Eye drops, and Saline)

Certain pharmaceutical dosage forms need to be supplied as Sterile products. The term Sterile denotes freedom from any viable microorganism. Viable microorganisms are germs that are not visible to the naked eye but can be viewed under a microscope; these can cause infections.  Therefore, products, such as injections, eye drops, and saline solutions, are designed…

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Product complaints

In pharmacovigilance product complaints pertain to the warnings or reports received by regulatory agencies, pharmaceutical manufacturers, or healthcare specialists concerning any issues, or problems connected with the quality, safety, efficacy, or usage of a medicine. Different sources are a reason for the arising of these complaints such as patients, providers of healthcare, pharmacists, or even…

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Adverse reactions

Adverse reactions following medical treatments are frequent and known. Physicians prefer the term 'adverse reaction' over 'side effect' because the latter suggests effects beyond pharmacological actions. Studies indicate that 5% to 30% of patients experience adverse events that are unpleasant experiences reported by the patients and not necessarily due to a specific medicine. Therefore, understanding…

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Good manufacturing practices for non-sterilized medical instruments and consumables

Healthcare management requires several different types of product range of which medical instruments and consumables are very important. These products are typically designed and manufactured in a clean environment to minimize contamination from viable organisms. These products are often intended for procedures or situations where the risk of infection is low. Common types of non-sterilized…

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Good manufacturing practices for oral dosage forms (Tablets, capsules, powders, granules, syrups)

Oral dosage forms are pharmaceutical formulations designed for administration by mouth, offering various options to cater to different age groups and patient needs and drug properties. Tablets are solid, compressed forms containing active ingredients and excipients, ideal for precise dosing and stability. Capsules encase the drug in a gelatin or non-gelatin shell, facilitating easier swallowing…

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Good manufacturing practices for external application products (creams, powders, topical gels, ear drops)

Every pharmaceutical product needs to be free from viable bacteria, yeast and fungi. The principles of GMP therefore mandate manufacturing hubs to be clean and free from such contaminants.  The clean room concept is based on maintaining high hygiene areas that are free from such contaminants. Topical and external application preparations do not require to…

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WHO repository on pharmacovigilance

The World Health Organization (WHO) maintains a database globally called the "WHO Global Individual Case Safety Reports (ICSRs) Database," also identified as "VigiBase." This is principally a repository for data on pharmacovigilance. A pivotal role is played by the WHO repository in global clinical trials and as well as on all the marketed pharmaceutical products.…

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Pharmacoeconomics- An overview

Individuals lead intricate lives, where a multitude of elements determine their ability to afford necessary medication for treating illnesses. Similarly, our markets are equally complex entities, shaped by various factors. Globally, patients struggle with the medication’s exorbitant costs. In developing countries such as India, a surprising 85% of the overall expenses in health is covered…

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Determinants of Pharmacoeconomics

Health economics consists of an important field namely pharmacoeconomics, which estimates the influence of pharmaceutical interventions economically. It counts an array of factors influencing the drug’s value and cost-effectiveness in systems of healthcare throughout the world. A crucial role is played by clinical trials globally in supplying facts on a pharmaceutical’s efficacy, safety, and comparative…

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Unveiling the Necessity of Pharmacoeconomics

Pharmacoeconomics is the branch of <<health economics>> and it helps in forming an economic relationship between drug research, its production and distribution. Thus, the application of the principles of pharmacoeconomics involves implementing pharmacoeconomic principles, methods, and theories to measure the "value" of a pharmaceutical product and the services that it offers when used in real-world…

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