Month: December 2022
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New Drug A Live Virus Carrying Gene, A Gene Therapy approved by USFDA for treatment of Bladder Cancer that is non metastatic and don’t respond to other treatments like BCG
Novel drug Adstiladrin that delivers genes through a live virus vector, approved by USFDA for treatment of non-muscle invasive Bacillus Calmette-Guérin (BCG)-unresponsive bladder cancer. This month the US FDA has approved a novel drug, a gene therapy that makes use of a live virus (vector) which carries the gene and delivers it to the point…
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How to Maintain data integrity in Pharmaceutical Industry
Maintaining the integrity of data in pharmaceutical industry. What is data integrity How to Maintain data integrity in Pharmaceutical Industry Integrity is a principle of being truthful and honest towards the work and data generated through work by inculcating and practicing strong moral and ethical principles while doing work in an organization or as an…
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Modular Clean Room in Pharma Industry
Modular Clean room in Pharmaceutical Manufacturing Facility Modular clean room are the solution where higher degree of cleanness is required in some places like pharmaceutical manufacturing and in healthcare and Space and computer chip manufacturing places. Particle contaminants are not just particles but they harbor bacterial as well as fungal and viral contaminants, therefore it…
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What is a Clinical Trial Clinical Research
What is Clinical Trial Clinical Research. Clinical trials is a activity to identify and develop a safe and effective medicine or a treatment for a disease, symptom of a disease. Patients or people participating in new research are at benifit of getting a latest newer treatment or medicine for the disease. Clinical Trial Definition: Clinical…
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Cholesterol level limit
What is cholesterol why it is harmful/ dangerous when its level in body increases. Cholesterol level limits chart testing monitoring Cholesterol has some important functions in our body, it is required to forms membrane wall of cells in our body, and maintain cellular physical properties and integrity. Cholesterol is classified in three categories. 1)High Density…
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Judgment of a market complaint if it is a Genuine or counterfeit
I was asked today if I am a good Judge to identify if a market complaint is a fake. Or is it a genuine, to understand that there very important aspects that one must know are. Product history, knowledge about competitors product, and the ability to find out genuine root cause. If you can identify…
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Lenacapavir new antiretroviral drug for multi drug resistant HIV infection approved by USFDA
New anti-retroviral drug Lenacapavir approved by USFDA for treatment of multi drug resistant HIV 1 infection. On 22-Dec-2022 United States Food and Drug administration approved a new drug for treatment of HIV-1 infection, for patients where other drugs were developing drug resistance (Multi drug resistance). Name of Drug approved by the US FDA is Sunlenca which…
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Data Integrity how to maintain Data Integrity
Data Integrity is very important aspect of pharmaceutical good manufacturing practices. We have provided here a presentation for training personnel in Pharmaceutical manufacturing company.
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Quality management system in Pharmaceutical Company
Quality management system in a pharmaceutical manufacturing company What is quality management system QMS in pharma company? Following functions all together when driven together forms, every function is more or less interlinked or impacting other, therefore systematic operating of every function is important to achieve compliance and quality aspects as defined in guidelines of regulatory…
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Important aspects of Deviation how to handel
What you should know for effective handling deviations in a pharmaceutical company Definition of Deviation: Any observed and non-observed departure of value or an event or procedure or action from set parameter, written and approved standards or acceptable limits or statements is called as deviation. If someone do not follow or finds a difference in…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 