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Pharma Regulatory Bodies Worldwide

Regulatory bodies in the pharmaceutical industry play a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products. Here are some of the key regulatory bodies from various regions around the world: Food and Drug Administration (FDA) – USA: The FDA is responsible for regulating pharmaceuticals in the United States. It reviews and approves new drugs, monitors drug…

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88 Pharmacy Graduate Job Openings Under GSSSB - Secure Your Government Career Now!

Online application forms are invited from the candidates on the website of OJAS for preparation of selection/waiting list in the direct recruitment process for filling up the following direct recruitment posts by direct recruitment under the control of Director, Justice Assistant Scientific Office under the control of Home Department by Gujarat Secondary Service Selection Board, Gandhinagar.…

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Accreditation 

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Role of Accreditation as per ISO17025 standard in enhancing the quality and reliability of Pharmaceutical Testing

Laboratories Accreditation by ISO/IEC 17025 plays a crucial role in enhancing the quality and reliability of pharmaceutical testing laboratories. Here’s how it helps: Ensures Technical Competence: ISO/IEC 17025 is focused on the competence of testing and calibration laboratories. It ensures that a laboratory has the appropriate equipment, trained staff, and validated methods to perform tests…

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(via GAMP)

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GAMP in Pharmaceutical Industry

GAMP, or Good Automated Manufacturing Practice, is a set of guidelines and best practices for designing, implementing, and maintaining automated systems in the pharmaceutical industry. Developed by the International Society for Pharmaceutical Engineering (ISPE), GAMP aims to ensure that automated systems used in the production of pharmaceutical products are compliant with regulatory requirements…

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Analytical Method Transfer (AMT) and its significance in pharmaceutical manufacturing

Analytical Method Transfer (AMT) is the process of transferring analytical procedures and methodologies from one laboratory to another. Consequently, this ensures consistency, reliability, and regulatory compliance in drug development and manufacturing processes. This transfer is typically done to ensure consistency, reliability, and regulatory compliance in drug development and manufacturing…

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Bracketing and Matrixing Designs for Stability Testing

Reduced study designs, in the context of pharmaceutical development and stability testing, refer to approaches that allow for a reduction in the number of samples and/or time points for testing while still ensuring the reliability and validity of the data. The concept of reduced study designs aligns with the guidelines provided by the ICH.. These designs can help save time and resources without…

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Antioxidant and it's benefits

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5 Why tools for Root cause analysis in pharmaceuticals

Originating in the manufacturing industry, the “5 Whys” analysis technique has found effective adaptation and application in various fields, including pharmaceuticals. It involves asking “why” multiple times (typically five) to dig deeper into the root causes of a problem. In the context of pharmaceuticals, the 5Whys tool can help identify the underlying causes of quality issues, compliance…

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Evaporative Light Scattering Detector(ELSD)

ELSD stands for Evaporative Light Scattering Detector. It serves as a type of analytical instrument in chromatography for detecting and quantifying non-volatile compounds lacking a natural chromophore or fluorophore. It proves especially valuable when analyzing compounds that UV, fluorescence, or conductivity detectors, commonly used in chromatography, cannot detect. How ELSD…

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Refractive Index Detector (RID)

A Refractive Index Detector (RID), also known as a Refractometer or Refractive Index Detector, is a detection device commonly used in High-Performance Liquid Chromatography (HPLC) and other liquid chromatography techniques. RIDs operate based on the principle of measuring changes in the refractive index of a sample as it elutes from the chromatographic column. Here are its key features,…

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Fluorescence Detectors(FLD)

Fluorescence Detector (FLD) is a specialized analytical instrument used to detect and quantify fluorescent compounds in various samples. It operates on the principle of fluorescence, a process where molecules absorb light at one wavelength and then re-emit it at a longer wavelength. Here are the applications and uses of fluorescence detectors: Applications of Fluorescence Detectors: Analytical…

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Diode Array Detector

Diode Array Detector (DAD), also known as a UV-Visible Detector, is a type of detector commonly used in analytical chemistry techniques like High-Performance Liquid Chromatography (HPLC) and other forms of liquid chromatography. It differs from a single-wavelength UV detector in that it can simultaneously measure absorbance at multiple wavelengths across the UV-Visible spectrum. Here are its…

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UV VIS Detector and it's application

A UV-Vis (Ultraviolet-Visible) detector is a common analytical instrument used in chemistry and biochemistry to measure the absorbance of ultraviolet and visible light by a sample. Principle and Component of UV-Vis Here are some key points about UV-Vis detectors and their applications: Principle of Operation: UV-Vis detectors operate based on the principle that molecules absorb light at…

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Different Types of HPLC Detectors

High-performance liquid chromatography (HPLC) detectors are essential components of HPLC systems that help identify and quantify analytes in a sample as they elute from the chromatographic column. There are various types of HPLC detectors, each with its own strengths and limitations. Here are some common types of HPLC detectors: UV-Visible (UV-Vis) Detector: UV-Vis detectors are one of the most…