New Options for HIV positive patients treatment will be available soon for daily dose of ART in HIV positive patients treatment

Treatment of HIV positive patients requires daily dose of ART (Antiretroviral Therapy) medicines which are a combination of many anti-retroviral drugs combined together. Combination ART drugs prescribed to HIV positive patients to keep their viral load under control and are very effective in providing protection against HIV to patients. Daily dose of antiretroviral medicines also has some side effects like  ART related […]

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Betalactam Antibiotics require 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 mode of action is more or […]

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Automatic Insulin Pump that work in conjugation with blood glucose level sensor for children above 7 years age

Type 1 Diabetes patients are required to take Insulin through regular injections in hypodermic Insulin syringes since type 1 diabetes patients body do not produce or produce insufficient amount of Insulin hence blood glucose level remains higher,  therefore type 1 diabetes patients are required to take dose of insulin through injections in daily repeated dosages. Type 1 diabetes is observed […]

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Sterilization Various methods of Sterilization Pharma

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 growth.There are following method used […]

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USFDA Guidelines quality audits 21 CFR Sec.820.22 Medical devises

 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 state of compliance. In event […]

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Air Lock Types of Airlock Sink Airlock Cascade Bubble Airlock Types of Filters Clean up time

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 particle control and passage outside. […]

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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 be used in any Pharmaceutical […]

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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 ?  Yes It is mandatory by […]

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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 of drugAn article or substance that […]

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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 laminar air flow cabinet can […]

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