Rare diseases, also known as orphan diseases, affect a small percentage of the population. Despite their rarity, the cumulative impact is significant, with approximately 300 million people worldwide suffering from…

Introduction - The Annual Product Quality Review (APQR) in the pharmaceutical sector is crucial for evaluating product quality and guaranteeing regulation adherence. This thorough assessment procedure considers several important elements…

IQ, OQ, PQ: Essential Steps for Equipment Qualification Introduction - Activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly" is what the…

Introduction - In the pharmaceutical sector, validation is a crucial process that guarantees medication efficacy, safety, and quality. It's a procedure mandated by many regulatory bodies that entails several meticulously…

GMP: What is it? The U.S. Food and Drug Administration (FDA) has established Good Manufacturing Practices (GMP) as a collection of guidelines to guarantee that drugs are produced and controlled…

Introduction - Healthcare and pharmaceuticals are among the numerous areas in which artificial intelligence (AI) is revolutionizing. The potential uses of generative AI, which can create new data based on…

PRODUCTS HAVE TO BE STERILE Certain pharmaceutical products, such as injections, eye preparations, irrigation solutions, and hemodialyzer solutions. TWO SERIES OF INDIVIDUAL PRODUCTS Those that are terminally sterilizable or able…

Introduction: The amount of microorganisms contaminating an object is measured as its bioburden, often known as its microbial load. Before being used, any lot of a component, medication product container,…

Introduction - It is vital for any company selling pharmaceuticals to comprehend the regulations governing the labeling and packaging of those goods. Pharmaceutical manufacturers and customers alike have severe concerns…