Critical process parameters is an abbreviation of CPPs and CQAs is critical quality attributes. In this article we will learn what are the basic differences between critical process parameters and critical quality attributes and what is the relationship between these two...

Chemical, physical, biological or microbiological characteristics or properties of a drug product must be controlled within a defined limit or range to ensure product quality...

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

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 ...

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 ...

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 ...

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 ...