Category: Uncategorized
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Validation Master Plan Definition of Validation Master Plan
What is the Validation Master Plan Definition of Validation Master Plan? Why is the validation master plan important in the Pharmaceutical Manufacturing Industry? Is it made mandatory by US FDA to make A Validation Master Plan ? No it’s not Mandatory by USFDA Guidelines. Is Validation Master Plan document Mandatory as per WHO Guidelines ? …
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Drug definition US FDA Drug approval process
Definitions of a drug, Radioactive Drug, Radiopharmaceuticals, Investigational New Drug or Device, Drug product, Drug substance, What is an orphan drug. Definitions of a drugWhat is a drug: Any chemical compound that may be used on or administered to humans to help diagnose, treat, cure, mitigate, or prevent disease or other abnormal conditions Regulatory definition…
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What is a Laminar Air Flow Cabinet.
What is a Laminar Air Flow Cabinet. Laminar air flow cabinets can provide a clean room environment of class 100 and below, which is attained by filtering air through HEPA filters , they can remove particulate matter of dimension 0.3 nm and above with an efficiency of 99.997 to 99.999.Hence an appropriately designed and maintained…
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Liposome Liposomal drug delivery system
What is liposome limposomal drug delivery system:Liposomes are small vesicles made up of phospholipids, the very similar constituent of cell membrane, so that the pospholipid vesicles behave more or less as a micro cell inside which drug molecules can be loaded . The phospholypid molecule is made up of hydrophylic head ( containing choline, phosphate, and…
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Type 1 Diabetes and treatment Reason why type 1 diabetes occur
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…
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Contract Manufacturing available at Raptakos Brett & Company
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.…
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Corrective And Preventive Action Pharma CAPA
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…
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Why Betalactam Antibiotics require a separate manufacturing area in pharmaceutical manufacturing company
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…
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USFDA Guidelines for Pharmaceutical Manufacturing Current Good Manufacturing Regulatory Guidelines
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…
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Biosimilar or interchangeable biopharmaceutical.
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…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 