Month: May 2022
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What is FAT SAT for Pharmaceutical
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…
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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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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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Definitions of a drug Different Types of Drugs
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…
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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…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 