The Pharma Journal

 ICH Q9 guidelines are known as Quality Risk Management issued by International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This guidelines gives description on how the Quality Risk Management can be applied to uphold the quality of medicines in Pharmaceutical Industry. This guideline also covers development, Manufacturing and Distribution including whole life cycle of medicinal products. Quality Risk Management can be defined as a systematic assessment of risks and a approach to control and communicate such risk to enhance Quality of product. Principle of Quality Risk Management: The principle includes Evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient and the level of effort, formality and documentation of the quality risk management process should be in correspondence with the level of risk. Process of Quality Risk Management: The Quality Risk Management f...

 If you go back to 2018, Nitrosamines presence in the drug product were not known to the World. But since then, when  USFDA found the presence of Nitrosamines in the drug Products like Valsartan and Ranitidine, It became talk of the year in Pharma field.                            Nitrosamines are the class of compounds which are usually found in the meet. This compound is considered as cancer causing agent in a research conducted by International Agency for Research on Cancer( IARC). Nitrosamines are probable cancer causing agent to humans.It was first found by USFDA in a valsartan Active Pharmaceutical Ingredient(API) manufacturer from china.              The game started when, All the regulatory authorities like FDA, EMA, WHO,Health Singapore and even Indian CDSCO started to issue orders to the manufacturers to recall their products from the market and submit the product...

1.WHO defends data after concluding Gilead's remdesivir flopped Covid-19 trial:- Gilead sciences Inc has questioned the findings that concluded remdesivir does not help patients who have been admitted to hospital, saying the "emerging (WHO) data appears inconsistent". Gilead was given data from the United Nations health agency's trial 10 days ago, to give it an opportunity to react. 2.  Zydus Cadila gets USFDA nod to market Fingolimod capsules, Verapamil Hydrochloride Injection:- Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Fingolimod capsules, (Gilenya) in the strengths of 0.5 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing. 3.  Chinese Covid-19 vaccine candidate shows promise in human trial: Study:- The latest study, published in The Lancet Infectious Diseases journal, included participants aged between 18 and 80 years and found that antibody responses were induced in a...