What is an Audit?
An audit is a methodical, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. (ISO 19011:2002, 3.1)
Before we discuss “GMP Auditing” in detail, let’s have a clear understanding of what does GMP mean in a regulated manufacturing environment?
GMP Defined
In short, Good Manufacturing Practices (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The diagram represents the elements in a manufacturing environment that fall under cGMP compliance where “c” stands for current.
GMP Audit Defined
So, what is a GMP audit?
In short: The review carried out to assess the degree of conformity to prescribed standards of good manufacturing practice and to evaluate compliance with the relevant regulatory requirements is called a GMP audit.