by Naveen kumar | Nov 5, 2024
1. The Indian Patent and Design Act, 1970 Focused on encouraging innovation, this act initially allowed only process patents, enabling Indian companies to produce affordable generic drugs. Over the years, the act evolved, aligning with international standards to...
by Naveen kumar | Nov 1, 2024
Understanding Why-Why Analysis in Pharmaceuticals: Uncovering the Root of Quality Issues The Why-Why analysis, or “5 Whys,” is a structured root cause analysis method widely used in the pharmaceutical industry to identify and resolve issues at their...
by Naveen kumar | Nov 1, 2024
Importance of Critical Process Parameters (CPPs) in Pharmaceutical Manufacturing Critical Process Parameters (CPPs) are key to ensuring product quality in the pharmaceutical industry. These parameters—such as temperature, pH, mixing speed, and pressure—are closely...
by Naveen kumar | Nov 1, 2024
Understanding the Difference Between Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) in Pharmaceuticals In pharmaceutical manufacturing, maintaining high product quality is essential, and two important concepts—Critical Quality Attributes...
by Naveen kumar | Nov 1, 2024
Disinfectant Validation in the Pharmaceutical Industry In the highly regulated world of pharmaceuticals, maintaining clean and sterile environments is essential to ensure product safety and quality. Disinfectant validation plays a critical role in this process,...