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.  

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 […]

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 […]

USFDA approves New Drug for treatment of Clostridioides difficile infection

Novel drug Rebyota for treatment of Clostridioides difficile infection  USFDA have approved first of its kind new drug for treatment of Clostridioides difficile infection. The drug is used as microbial inoculam in rectum, drug Rebyota is made from the fecal matter donated by healthy volenteers, it consists of microbial microbiota which help in supression of […]

New Drug approved by USFDA for Type 1 Diabetes

USFDA approves new drug that halts progression of Type 1 Diabetes. Type 1 diabetes is a very severe type of diabetes, type 1 diabetes patient’s pancreases produce very little of negligible amount of insulin which makes them diabetic, therefore patients affected with type 1 diabetes are required to take insulin injections throughout their lifetime. One […]

How to handle investigate and identify root cause of a market complaint of a drug product.

How to investigate market complaint Pharmaceutical

How to handle market complaint in pharmaceutical industry? One of the prime objective of addressing the market complaints or product complaint received from user is to 1) Prevent any loss to patient due to malfunctioning or faulty product. 2) To maintain the quality of the product by learning the root cause of the defect and […]

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