Is a pharmaceutical quality policy just the necessary fine print that nobody reads?
Not to industry leaders like Anders Vinther.
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.
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.
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
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.
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.
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
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.
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.