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  • A Glimpse on Quality by Design (QbD) Approach in Pharmaceutical Industry

    Quality-by-Design approach in Pharmaceutical Industry

    The concept of Quality by design (QbD) means signifies designing and developing pharmaceutical products and manufacturing processes to ensure predefined product quality objectives. Quality by Design (QbD) brings a systematic approach to drug development that aims to ensure quality by applying analytical and risk-management methodologies to design, development and manufacturing. The main concept of (QbD) … Read more

    Azithromycin: Drug Information

    Azithromycin Drug Information

    Azithromycin is an antibiotic medication used to treat a variety of bacterial infections, including respiratory tract infections, skin infections, ear infections, and sexually transmitted infections. It belongs to the macrolide class of antibiotics and works by inhibiting bacterial protein synthesis. Azithromycin is usually taken orally in the form of tablets, capsules, or liquid, and the … Read more

    Cephalexin: Drug Information

    Cephalexin Drug Information

    Cephalexin is a broad-spectrum antibiotic that is used to treat bacterial infections caused by susceptible bacteria. It is commonly used to treat the following infections: Cephalexin may also be used to prevent certain types of bacterial infections, such as in people who are at high risk of developing an infection after surgery. However, it is … Read more

    Ciprofloxacin: Drug Information

    Ciprofloxacin Drug Information

    Ciprofloxacin is a widely used antibiotic that belongs to the class of fluoroquinolones. It is primarily prescribed for treating bacterial infections such as urinary tract infections, respiratory infections, skin infections, and infections in the digestive system. Ciprofloxacin works by inhibiting the enzymes that bacteria need to replicate, preventing the spread of infection. This antibiotic is … Read more

    COVID-19 Vaccine and Development Stages

    COVID-19 Vaccine and Development Stages

    COVID-19 vaccine, the world is expecting early because the rate of infection across the world is much higher than expected. India is the second-worst affected country hit by the epidemic, with over 1. 2 million cases. The virus spread rapidly and the majority of the world’s population is susceptible to it. Scientists and medical researchers … Read more

    Data Integrity – General consideration and current understanding of the Pharmaceutical industry

    Data Integrity – General consideration and current understanding of the Pharmaceutical industry

    Data integrity is an important and current top issue for many regulatory authorities these days as many pharmaceutical industries found multiple problems due to poor practices followed during the development and commercialization of products for the patients. In the current scenario, the data integrity has been extended throughout the life cycle of products with the … Read more

    Data Integrity and its Compliance

    Data Integrity and its Compliance

    In the Pharmaceutical industry, data Integrity plays a pivotal role as it judges the safety and quality of pharmaceutical products. Data Integrity (DI) is very important as it ensures the authenticity of data and information obtained in the production and control of pharmaceutical products. Data Integrity and its role In Pharmaceutical Industry during recent years … Read more

    Effect of Hydroxychloroquine on COVID-19

    Effect of hydroxychloroquine on COVID-19

    What is Hydroxychloroquine? CAS Number – 118-42-3Molecular Formula – C18H26ClN3OMolecular Weight – 335.872 g/mol Hydroxychloroquine is a disease-modifying anti-rheumatic drug (DMARD). It regulates the activity of the immune system, which may be overactive in some conditions. Hydroxychloroquine can modify the underlying disease process, rather than simply treating the symptoms. Recent studies have shown that both … Read more

    Good Manufacturing Practice (GMP) Considerations for Responding to COVID-19 Infection in Employees in Drug & Biological Products Manufacturing

    GMP Practice Considerations for Responding to COVID 19

    In June 2020, FDA released Guidance for Industry (GFI) entitled “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing”. FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding: Drug manufacturers are expected to prevent or mitigate potential adverse effects on the safety … Read more

    Hand Sanitizer Use, Protection & Risk During the COVID-19 Pandemic

    Hand Sanitizer Use_Protection & Risk During the COVID-19 Pandemic

    Background Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) issued guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID19). SARS-CoV-2 has demonstrated the … Read more