What is type 1 diabetes Diabetes is a condition when our body is not able to handle sugar (glucose) in balanced manner , which result in further harmful health conditions like heart attack , High blood pressure, stroke and nerve damage, glaucoma , weakness fatigue , and wounds not healing for longer time. Therefore diabetes…
Contract Manufacturing facility available at Raptakos Brett & Co!!!. Contract Manufacturing Facility for Pharma Products : RBC is open for offering our services as a part of Contract manufacturing. Based on this decision, our manufacturing plant at Karad, ” A State of the Art Facility” design & dedicated for Tablets, Powder, Ointment, Cream and Syrup.…
Corrective and Preventive Action CAPA What is meant by CAPA In PharmaAs the title itself suggest CAPA is an important function of quality management system in pharma industry. Good manufacturing practices guidelines laid down by US FDA clearly mention that, a pharma company must have a prompt system in its quality management system which is…
Why Betalactam Antibiotics require a separate manufacturing aria in a pharmaceutical manufacturing company?Chemistry behind the allergic reactions and mode of action of betalactum antibiotics: Answer:To avoid cross contamination of other products with betalactam antibiotics because A.The betalactum antibiotics may cause anaphylactic shock and anaphylaxis or may cause life threatening allergic reactions. B.The betalactum antibiotics molecules…
Which are the US FDA regulations for Pharmaceutical Manufacturing industry acrros world for cGMP What is 21 CFR: It’s code of federal Regulations, Regulations on Pharmaceutical and Cosmetics and Medical devises are provided inter Title 21 hence CFR when referred with 21 CFR means the federal regulations for Drugs and Cosmetics. 21CFR Part 314 is…
What is a Biosimilar or Interchangeable Biopharmaceutical.Biosimilar is a term used for a biopharmaceutical which produces a preferred and similar pharmacological, biochemical activity or effect as compared to a biological or biopharmaceutical which is approved by FDA. in order to get an FDA approval for a biological product as biosimilar or as interchangeable biopharmaceutical a manufactures is required…
Principle of Spectroscopy: UV/Visible spectrophotometer: UV spectrophotometer is an instrument which makes use of light in the wavelength in the range of visible, near visible, infrared and near infrared range for identification and quantification analysis of pharmaceuticals.Light consist of many wavelengths in it and when it passes through a solution of a drug, drug molecule…
Sterilization indicator Biological Sterilization Indicators for different sterilization processAs per 21 CFR 880.2800(b) Sterilization indicators are defined as a device which are to monitor efficacy of sterilization process by monitoring the temperature, and other sterilizing conditions. A chemical indicator is required to be used along with a biological sterilization indicator. There are many line in chemical sterilization indicators available which…
Chromatography: Chromatography is a technique to separate different molecules of organic origin from each other; every organic molecule is different from other in its physical properties, and owing to this difference they tend to get separated from each other while migrating in the form of solution over a solid surface, every molecule get separated from…
Gene therapy and its application in medicine. Synthesis of amino acids and proteins and many essential biochemical’s which are required for normal functioning of our body is regulated by DNA in our body , which consists of specific genes over them which are responsible for coding for biochemical’s proteins responsible for normal functioning of our…