Sterilization Various methods of Sterilization in Pharmaceutical manufacturingSterilization is a process of rendering an object or articles or substance free from all viable microorganisms, (bacteria , fungi , virus) here term viable is used because there might not be a living organism present after sterilization but its spores might germinate and give raise to microbial…
USFDA in its guidelines on Quality System, it has mentioned guidelines regulations, means it’s mandatory for pharmaceutical manufacturing units to follow the Guidelines. US FDA in its guidelines on Quality audists mention that Pharma Manufacturer must have a Procedure for quality audits, these must ensure and establish that Quality systems are followed and are in…
Air lock: Air lock is a system formed in the form of a small room which has entry in and exit doors, entry doors are kept open while exit doors are kept closed. Air flow is controlled in the room so that it prevents contamination of air of inside clean room of higher level of…
What is FAT SAT for Pharmaceutical Manufacturing Equipment, machinery. Equipments in Pharmaceutical Manufacturing are required to of very good quality and Good Standards, by GMP guidelines, FDA regulations. Pharma Equipment’s Machineries are required to produce accurate results throughout the life span or predefined usage life span of that equipment for which it is going to…
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 ? …
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 ? …
Definitions of a drug, Radioactive Drug, Radiopharmaceuticals, Investigational New Drug or Device, Drug product, Drug substance, What is an orphan drug. Definitions of a drug. What 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…
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…
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…
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…