The Quality Policy of Pharmaceutical Industry

The Quality Policy of Pharmaceutical
Industry Leaders Includes These 5 Things

Is a pharmaceutical quality policy just the necessary fine print that
nobody reads?
Not to industry leaders like Anders Vinther.
Listen to the audio version of this article read by a real person

here (Sound on!):
When Vinther took over as Chief Quality Officer at Sanofi Pasteur,

he took a long, hard look at the quality policy. His company’s
quality policy was designed to meet GMP, which Vinther knew
was important because, he says, “we want medicines to be the
same quality — batch after batch after batch.”
Vinther understood rigid standards were important, but he also

knew the quality policy influenced culture. He didn’t want
“traditional procedures and controls,” which were barriers to
innovation. “The way that we approached quality in the past is not
the way that we should be approaching quality today,” says
Vinther. He set out to create an updated policy that emphasized
ongoing quality improvements and organizational agility.
Vinther next worked closely to collaborate with Sanofi Pasteur

employees on new SOPs, ensuring that new documents
explained the “why” behind procedures, linking the individual’s
role to the company’s mission. He created a shift in thinking about
quality by simplifying the policy and systems, along with adopting
new technologies for collaboration.
Many pharma industry leaders are discovering that the quality
policy is a lot more than necessary legal fine print, just like
Vinther. An effective quality policy is a cultural framework that
shows the team and customers the standard for consistently
delivering the best pharmaceuticals possible.
By learning from the quality policies of pharmaceutical industry

leaders, you can ensure that your team and customers
understand how dedicated you are to the highest quality possible.
5 Essential Parts of the Quality Policy of Pharmaceutical

Industry Leaders
A pharmaceutical quality policy is a statement or principle of
action which describes an organization’s commitment to quality
operations and products. It’s a brief policy built on the
pharmaceutical company’s objectives, purpose, and regulatory
responsibilities which describes the commitment to continual
quality improvement.
Creating, maintaining, and communicating this policy is the

responsibility of top management within the ISO 9001 framework.
The quality policy isn’t the same as the quality manual, quality
management system (QMS), or standard operating procedures
(SOPs). It’s not prescriptive, and it doesn’t tell anyone how to do
anything. Instead, the policy is a declaration of why your company
is committed to a quality-driven culture.
Your quality policy is a baseline for building an effective QMS and

SOPs. You can think of it as the non-optional foundation for
your pharmaceutical QMS. The quality policy is upheld by
management support and the right systems, like Vinther
discovered. A policy which prescribes quality as a value-add
activity is put into action with an agile cloud QMS software
like Qualio, which is built with the needs of small and growing life
sciences companies in mind. You can learn more about our
solution here.
1. Quality Intentions and Direction of the Company
Context is a very important ingredient for crafting a quality policy.

ISO 9001:2015 requires the quality policy is appropriate for an
organization's strategic and operational directions. It needs to
describe briefly who your company is, who you serve, and why
quality matters to the organization. Generally, intentions and
directions are the first sections of a policy.
Example:
It is Akorn's policy to preserve and improve patient health by

consistently delivering high quality, safe and effective specialty
pharmaceutical products, that meet or exceed customer
expectations. Source: Akorn
2. Intention to Comply with Regulations
A quality policy must address your organization’s intent to fully

comply with regulatory requirements. It doesn’t need to describe
how you’ll uphold regulatory frameworks, however. It also doesn’t
need to describe which regulations you meet.
The compliance intention section should be kept short and avoid

nitty-gritty details. The quality manual and QMS put regulatory
compliance into action, not the policy.
Example:
Pfizer’s business is conducted in compliance with applicable
quality regulations, codes and standards ... Records,
documentation and data are managed in accordance with
applicable regulations. Source: Pfizer
RELATED READING: The Essential Tools You Need to Achieve

Total Compliance in the Pharmaceutical Industry
3. Commitment to Continual Improvement of the PQS
Continual improvement is the goal of the pharmaceutical quality

system (PQS), according to ISO 9001 and ICH Q10 standards.
Your quality policy should address your organization’s
commitment to continually getting better. It doesn’t need to
describe the mechanisms for continuous improvements, such as
CAPA or management review. Instead, it should address
improvement briefly.
Example:
We continuously review our various operations to make them

more efficient, relevant with changing international scenarios ...
We stringently adhere to implementing Quality Management
Systems and are committed to making continual improvements to
the same. Source: BDR Pharma
4. Code of Ethics
A quality policy is a cultural foundation that should address the

“why” behind this policy. Quality is closely tied to ethics in pharma
because patient safety is the right thing to do. Your policy should
briefly address cultural values for ethical operations, such as
integrity. In addition, it should mention any ethical standards
adopted by your organization, such as the AdvaMed code of
ethics.
Many organizations elect to create a separate code of ethics

which further describes company values and standards for ethical
operations. You may decide this is valuable for your organization.
However, a separate code of ethics shouldn’t replace a mention
of your ethical code in the quality policy or a link between these
documents.
Example:
As a member company of The Advanced Medical Technology

Association (AdvaMed), Radiometer America Inc., and its division
HemoCue America, have adopted and complies with the
AdvaMed Code of Ethics. Source: Hemocue
RELATED READING: The 8 Essential Elements of Quality

Management For Pharmaceutical Companies
5. Code of Conduct
Your quality policy shouldn’t be a substitute for comprehensive

conduct standards for employees. Remember, the quality policy is
a general-purpose document that serves leadership, employees,
and customers. It should briefly address your standards for quality
conduct, and if applicable, link to a separate document that
provides in-depth conduct guidance.
Example:
The rules of conduct that are contained in the organization and
management model are supplemented by those of the Code of
Ethics that was also introduced by the company. In this way, a
total body of internal regulations has been created with the
purpose of disseminating the culture of ethics and transparency
within the company by offering the employees a kind of guideline
for their everyday behavior within the company and to implement
the organization and management model in accordance with
Italian Legislative Decree 231/01. Via Prinoth
Examples of Pharmaceutical Quality Policies
The best pharmaceutical quality policies are short and sweet. If it

drones on paragraph after paragraph, people can’t remember it,
and employees certainly won't incorporate it into their daily work.
Some of the best quality policies in pharma are very brief and
broad-sweeping. They get to the heart of why your organization is
committed to quality. The most effective policies barely touch the
surface of your “how,” by addressing the QMS and culture without
too much detail. Here are a few examples to get you started
writing a rock-solid quality policy.
1. Pfizer
2. Akorn
3. BDR Pharma

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The Quality Policy of Pharmaceutical

Industry Leaders Includes These 5 Things

Not to industry leaders like Anders Vinther.

Listen to the audio version of this article read by a real person

When Vinther took over as Chief Quality Officer at Sanofi Pasteur,

Vinther understood rigid standards were important, but he also

Vinther next worked closely to collaborate with Sanofi Pasteur

By learning from the quality policies of pharmaceutical industry

5 Essential Parts of the Quality Policy of Pharmaceutical

Creating, maintaining, and communicating this policy is the

Your quality policy is a baseline for building an effective QMS and

1. Quality Intentions and Direction of the Company

Context is a very important ingredient for crafting a quality policy.

It is Akorn's policy to preserve and improve patient health by

2. Intention to Comply with Regulations

A quality policy must address your organization’s intent to fully

The compliance intention section should be kept short and avoid

RELATED READING: The Essential Tools You Need to Achieve

3. Commitment to Continual Improvement of the PQS

Continual improvement is the goal of the pharmaceutical quality

We continuously review our various operations to make them

A quality policy is a cultural foundation that should address the

Many organizations elect to create a separate code of ethics

As a member company of The Advanced Medical Technology

RELATED READING: The 8 Essential Elements of Quality

Your quality policy shouldn’t be a substitute for comprehensive

Examples of Pharmaceutical Quality Policies

The best pharmaceutical quality policies are short and sweet. If it

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