An Overview of Concept of Pharmaceutical Validation

Drugs are the most important elements in healthcare and must be manufactured to the highest quality levels. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry. Process validation performs this task ensuring that the process does what it purports to do. The process validation is establishing documented evidence which provides high degree on assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristic. Validation is the art of designing and practicing the designed steps alongside with the documentation. Process validation emphasize on process design elements and maintaining process control during commercialization and communicate that process validation is an ongoing program and align process validation activities with product lifecycle. According to GMP validation studies are essential part of GMP and required to be done as per predefined protocols. Process validatio...