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Pharmaceutical QA: Understanding and Implementing ICH Q9 Guidelines The pharmaceutical industry operates within a highly regulated framework to ensure that products meet the highest standards of quality, safety, and efficacy. One of the core guidelines for managing quality risk in the pharmaceutical industry is the International Council for Harmonisation (ICH) Q9 Guideline on Quality Risk…
In the pharmaceutical industry, obtaining approval from the U.S. Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) is a critical step toward bringing generic drugs to market. However, this process often involves receiving deficiency response letters from the FDA. These letters—Discipline Review Letters (DRLs), Information Requests (IRs), and Complete Response Letters…
Navigating Post-Approval Changes: Best Practices for Regulatory Compliance: In the pharmaceutical industry, the journey of a drug doesn’t end with its approval. Post-approval changes are a critical aspect of ensuring that a drug remains safe, effective, and of high quality throughout its lifecycle. Navigating these changes while maintaining regulatory compliance can be complex and challenging,…
Understanding Process Analytical Technology (PAT) Tools: Revolutionizing Pharmaceutical Manufacturing Writer : Dr Nagendraa K Singh Director & Lead Global MS&T Capability Hub Sandoz Process Analytical Technology (PAT) tools are reshaping the pharmaceutical manufacturing industry by enabling real-time monitoring, analysis, and control of production processes. This proactive approach ensures consistent product quality, compliance with regulatory standards,…
Do you review or Do you preview ? By Sauri Gudlavalleti Picture this: You’re stuck in traffic, late for your engagement, anxiously staring at the Google Maps app on your phone – and the app is flooding you with copious amounts of information about how you got this far – average speed, number of turns,…
Process Validation in the Pharmaceutical Industry: Ensuring Consistency and Quality Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, quality, safety, and efficacy are paramount for patient health. To achieve this, manufacturers must ensure that their processes consistently produce products meeting these standards. This is where process validation plays a vital role. A well-validated…
What is CAPA and Why It’s Mandatory in Pharmaceuticals? Written By : Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, Corrective and Preventive Action (CAPA) is one of the most critical aspects of quality management. CAPA plays a pivotal role in maintaining product safety, efficacy, and compliance with regulatory standards. Let’s explore what…
Understanding Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) in Pharmaceuticals Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, ensuring that drugs meet the highest standards of quality, safety, and efficacy is paramount. Two key concepts that play a significant role in maintaining these standards are Critical Quality Attributes (CQAs) and Critical…
Ensuring Compliance with 21 CFR Part 11 in Pharmaceuticals Written By : Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, data integrity, security, and traceability are essential for maintaining high-quality standards and ensuring patient safety. 21 CFR Part 11, a regulation established by the U.S. Food and Drug Administration (FDA), is crucial in…
GLP-1 Single, Dual, and Triple Receptor Agonists for Treating Type 2 Diabetes and Obesity: A Comprehensive Narrative Review Introduction The global burden of obesity and type 2 diabetes mellitus (T2DM) continues to rise, affecting millions of individuals worldwide. Obesity and T2DM are intertwined, with obesity being a major risk factor for developing insulin resistance and…
