Category: Pharmaceuticals & Biologics

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…

Data Integrity Written By : Dr. Dhriti Tupe, GxP Expert ® What is Data Integrity and Its Importance in Pharmaceuticals? Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. In the pharmaceutical industry, it is paramount as data serves as the foundation for research, development, manufacturing, and regulatory decisions. Any…

Everything You Need to Know About LC-MS Sample Preparation By Xenia Xu Liquid Chromatography-Mass Spectrometry (LC-MS) is a powerful analytical technique that combines the separation capabilities of liquid chromatography with the detection and identification capabilities of mass spectrometry. However, proper sample preparation is crucial for obtaining accurate and reliable results. Let’s explore the key aspects…

What is HPLC, Why is it Important in Pharma, and What are its Phases? Written By : Dr. Dhriti Tupe, GxP Expert ® In the pharmaceutical industry, ensuring the safety, efficacy, and quality of a product is paramount. One key tool that plays an instrumental role in achieving this is High-Performance Liquid Chromatography (HPLC). But…

 Challenges and Complications of Poly(lactic coglycolic acid)Based Long Acting Drug Product Development Poly(lactic coglycolic acid) (PLGA) is a biodegradable copolymer approved by the FDA and EMA for use in drug delivery systems, particularly for long acting injectables (LAI) and implantable drug products. Due to its customizable degradation rates and biocompatibility, PLGA has been extensively used…