Standards

WHO Technical Report Series (TRS) 992 annex 4 provides basic guide for hold time studies to the manufacturers & GMP inspectors…

Disintegration and dissolution are two most commonly used terms in pharma industries but most of the people do not know the exact difference between these two terms. In this article we will discuss the following, What is Disintegration? Disintegration is the in vitro test which is performed by using basket rack assembly to check the

Validation is one of the most important and common terms used in pharmaceutical industries and its simple meaning is to provide a high degree of assurance or confirmation regarding product quality and system reliability. The concept of validation gives a high level of assurance that products manufactured in pharmaceutical industries are fit for use and

Qualification is documented evidence that all the equipment, system, facility, or utility are designed, installed, and operated in such a way that complies with GMP requirements and produces products of the desired quality all the time. Qualification is a part of validation and consists of following If we discuss in a detailed manner then some

Validation is documented evidence that gives assurance that a process will consistently produce a product with pre-defined specifications and quality. Validation is documented proof that a process, procedure, or activity will produce the same results in testing and production. Why Validation? Validation is the requirement of the FDA and other regulatory bodies that demand that