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.
For whom it (Quality Policy) is applicable?
Quality
policy is applicable for all the employees of an organization involved in the
process. They contribute to achieve the goal and objectives that is defined in
the quality policy. Quality objectives are defined by the Quality Policy, Top
management should ensure that quality objectives are known and widely used at
all levels within the organization.
Why Quality Policy is required to define?
It
can be says that it is a worldwide statutory requirement, to define the Quality
Policy of an organizations. It is also beneficial for an organization towards
the process of customer satisfaction.
In the
process of continual improvement, to deal with inevitable changes those arise within
and around the organization, Quality policy should be reviewed by the
organization for continuing suitability.
What is the regulatory aspect on quality policy?
✅ WHO says
“senior management of an organization should make a formal commitment to the
implementation of a documented quality policy that is compatible with statutory
requirements and relevant objectives”.
✅ USFDA says “senior management of an organization should incorporate
a strong commitment to quality into the organizational quality policy that
aligns with the mission; commit to meeting requirements and improving the quality
system; and propose objectives to fulfill the quality policy”.
We hope this article of total pharmaceutical topic helps you to refreshing your knowledge bucket; other useful articles may uplift the information stock of the mind.