How many phases are in performance qualification of purified water system?

What are the types of non-compliances in the internal audit?

Describe the categories of the market complaints

What do you mean by “Reference standard” and “Working standard

Define stability study and its necessity?

Stability study is defined as “stability testing is to provide evidence how quality of product varies with time under influence of temperature, humidity & light”.

Stability study is essential because it helps to:

·         Establish a re-test period for drug substance 

·         Establish a shelf life for drug product

·         Recommend storage conditions for products