As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk…
Since the advent of Coronavirus disease, the whole world has gone crazy after two things i.e Hand Sanitizers and Face Masks. The fear of the disease has gripped everyone so much that people who didn’t have any exposure to the…
April 18, 2020 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has permitted the conduct of clinical trial of Convalescent Plasma In COVID-19 Patients. The trial protocol was developed and submitted by Indian Council of…
This is an evident fact that for any industry to grow, it has to constantly improve its processes and quality parameters. This becomes more important in case of highly regulated and constantly advancing industries such as pharmaceutical industry. There…
Apr 16, 2020 The U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cancer of the lining of the urinary system. “Although our nation’s…
Recent Post
- India Imposes National Ban on Nimesulide for Veterinary Use Due to Toxicity Risks
- Major Relief for MSME Pharma Manufacturers: MoHFW Extends Deadline for Revised GMP Compliance
- Pharmacovigilance system compliance in India
- Simplifying Clinical Trial Amendment Approvals in India
- Navigating Drug Rules in India: A Guide for Pharmaceutical Marketers