Standards

Hold Time Studies In Pharma

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

Difference Between Disintegration and Dissolution

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|Process validation

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|IQ|DQ|OQ|PQ|URS|FAT|SAT

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

Difference Between Validation and Calibration

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

Master Clock|Slave Clock In Pharmaceutical Industries

Time is a key factor for the success of any person or the organization.Time is also known as money and time can not be measured  precisely without a clock or watch.The concept of a master clock and the slave clock is to make time uniform and precise in all the areas of an organization so

Good Manufacturing Practice |GMP| Difference between GMP & cGMP

GMP stands for good manufacturing practice and it is a set of guidelines introduced by the US-FDA(Food and Drug Administration).In this article, we will read about  Definition of GMP GMP is a combination of procedures and documentation that confirms that all products are always manufactured according to quality standards. Explanation  Why GMP? It is a