Quality Policy; When we talk about the Quality management
system (QMS) in pharmaceutical industry, Quality
Policy is an important term within it. This term can be easily understood
by some of the below questions.
What is the definition of Quality Policy?
Term
“Quality Policy” is self defining term, means a policy or statement on Quality. In Quality management system (QMS) this term is used for a documented procedure, to give you an idea about commitment and strategic direction of the organizational management
towards Quality of the product. This
should be the aim of the organization.
WHO
says “A brief statement (Quality Policy Statement) that describes
the organization’s purpose, overall intentions and strategic direction,
provides a framework for quality objectives and includes a commitment to meet
applicable requirements”.
ICH says inline to ISO (9000:2005), “Quality
policy is an overall intention and direction of an organization related to quality
as formally expressed by the senior management”.
USFDA
defines Quality policy as “A statement (Quality Policy Statement) of
intention and direction issued by the highest level of the organization related
to satisfying customer needs. It is similar to a strategic direction that
communicates quality expectations
that the organization is striving to achieve”.
Who prepares Quality policy and why it is
important?
This
is responsibility of top management / higher management of an organization, to establish
a clear Quality policy statement.
Organizational quality objectives can be said “operational planning” should be
based on the Quality policy.