What is Clinical Trial : Any systematic study which is performed on pharmaceutical products in human body whether in patients or other volunteers, in order to verify the effect or to identify any adverse reaction, or to study absorption, distribution, metabolism and excretion of the products with their efficacy and safety. It is the only … Continue reading Clinical Trial Requirement and Rules
Month: April 2020
Working and Principle of Vibratory Sifter
Vibratory Sifter is used in Sifting of materials in Pharmaceutical manufacturing with different mesh of Sieves and it is widely used equipment in pharmaceuticals and in food industries. Uses of Vibratory Sifter : Sifting is done to remove lumps or growth that might have formed on the materials after being stored for a longer period … Continue reading Working and Principle of Vibratory Sifter
Working and Principle of Rapid Mixer Granulator (RMG)
The Rapid Mixer Granulator was used in pharmaceutical Industry and it is used to mix the pharmaceutical ingredients and make the granules. It is a part of Wet Granulation before Compression & Capsule Filling. It is also called high shear mixer. Different parts of RMG : RMG having different parts like Impeller, Chopper, Discharge port, … Continue reading Working and Principle of Rapid Mixer Granulator (RMG)
Over-the-counter (OTC) Drugs and Different Countries Regulation
Over-the-counter (OTC) drugs are the medicines that can sold directly to a consumer without a prescription from a healthcare professional. The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription Prescription Drugs are the medicines which may be sold only to consumers having a valid prescription. Prescription drugs require a prescription from a doctor and should only … Continue reading Over-the-counter (OTC) Drugs and Different Countries Regulation
Working & Principle of Tablet Compression machine
A tablet press is a mechanical device that compresses powder into tablets of uniform size and weight. A tablet press can be used to manufacture tablets of a wide variety of materials, including pharmaceuticals, Nutraceuticals, cleaning products, industrial pellets and cosmetics. To form a tablet, the granulated powder material must be metered into a cavity formed by two punches and a die, and then the punches must … Continue reading Working & Principle of Tablet Compression machine
5S in Pharmaceutical Industry
What is 5S System: 5S is a system for organizing spaces so that work can be performed efficiently, effectively, and safely. This system focuses on putting everything where it belongs and keeping the workplace clean, which makes it easier for people to do their jobs without wasting time or risking injury. 5S methodology has expanded … Continue reading 5S in Pharmaceutical Industry
Hold Time Study in Pharmaceutical Manufacturing
What is Hold time Study: Hold Time studies establish the time limits for holding the materials at different stages of production to ensure that the quality of the product does not degrade significantly during the hold time at a required temperature and Relative Humidity. Hold time can be considered as the established time period for … Continue reading Hold Time Study in Pharmaceutical Manufacturing
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Corrective Action and Preventive Action (CAPA)
CAPA is taken to correct or rectify the problem or incident or deviation or event etc. Corrective Action : An action taken to eliminate the cause of the existing deviation , incident or problem in order to prevent its reoccurrence (occurring again). Preventive Action : An action taken to eliminate the cause of potential deviation, … Continue reading Corrective Action and Preventive Action (CAPA)
Pharmaceutical Plant Contract Manufacturing and Contract Analysis as Per GMP
Earlier I have shared you the GMP Requirement for Pharmaceutical plant premises, Equipment's, Production, Training, personnel Hygiene, Self-Inspection, quality audits and suppliers’ audit, Personnel, Quality Control, and Complaints & Recall. There are various modules of GMP which I will share one after another & today’s module is Contract Manufacture and Contract Analysis. https://pharmaceuticalupdates-com.stores.instamojo.com/product/283953/all-modules-of-good-manufacturing-practices-gmp-for-pharmaceutical-products/ The Contract … Continue reading Pharmaceutical Plant Contract Manufacturing and Contract Analysis as Per GMP