In this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance Challenges What is not Quality Policy What is Quality Policy How to craft the Quality Policy · Importance Imagine that you are an owner of the Pharmaceutical Organisation; What should be your Policy towards patient safety? How your product should provide Quality and Safety assurance to patients… All GMP and ISO 9001guidelines are expecting from Top management “Top Management is responsible for establishing, reviewing, and maintaining the quality policy and quality objectives.” Do you know which document should be the first document of the Pharmaceutical Organisation? The Answer is QUALITY POLICY… By this Document, the regulatory is accessing the thought process of top management. · Challenges Every Owner of the Pharmaceutical Organisation facing challenges for QUALITY POLICY… How to develop a document (QUALITY POLICY) which delivers correct thoughts to the entire origination, regulatory agency, and customer. How to implement the Quality Policy in the Organisation In many organizations, the Quality Policy is just printed on paper for documentation purposes, it may be framed and hanged, but nobody is reading it… Quality Policy is the document which is influenced the culture of the organization if it is implemented systematically. We have to understand “The traditional procedures and controls,” should not barriers to innovation. “The way that we approached quality in the past is not the way that we should be approaching quality today,” we have to set up an updated policy that emphasized ongoing quality improvements and organizational agility. The SOPs, ensuring that all the documents explained the “why” behind procedures, linking the individual’s role to the organizational Vision & mission. We should change our 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. An effective quality policy is a cultural framework that shows the entire origination, regulatory agency, and customer the standard for consistently delivering the best possible pharmaceutical product or service. · What is not Quality Policy The quality policy is not the same as the quality manual, quality management system (QMS), or standard operating procedures (SOPs). It is not prescriptive, and it does not describe anyone how to do anything. · What is Quality Policy The policy is a declaration of “WHY” your company is committed to a quality-driven culture. The quality policy is a baseline for building an effective QMS and SOPs. it is the non-optional foundation for pharmaceutical QMS. The quality policy is upheld by management support and the right systems, A policy which prescribes quality as a value-add activity is put into action with an agile · How to craft the Quality Policy Following Points should be considered while developing the Quality Policy A pharmaceutical quality policy is a statement/principle of action that describes an organization’s commitment towards quality operations and products. it should cover; 1. The intention of the top management towards Quality 2. The intention of the top management towards Regulatory requirement 3. Commitment to Continual Improvement 4. Code of Ethics 5. Code of Conduct 1. The intention of the top management towards Quality This 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, whom you serve, and why quality matters to the organization. this should be the first section of a policy. 2. The intention of the top management towards Regulatory requirement The quality policy must address the organization’s intent to fully comply with regulatory requirements. It doesn’t need to describe how you will uphold regulatory frameworks, however, It also does not need to describe which regulations you meet. The compliance intention section should be kept short and avoid more details. The quality manual and QMS put regulatory compliance into action, not the policy. 3. Commitment to Continual Improvement Continual improvement is the goal of the pharmaceutical quality system (PQS), according to ISO 9001 and ICH Q10 standards. The quality policy should address your organization’s commitment to continually getting better. It does not need to describe the mechanisms for continuous improvements, such as CAPA or management review. 4. Code of Ethics Ethical practices are an important part to maintain quality, patient safety is a prime responsibility of the organization. Hence; here how the code of ethics is impacting or controlling the quality of the product or service. However, a separate code of ethics should be prepared 5. Code of Conduct Here; we have to mention how the code of conduct is impacting or controlling the quality of the product or service. The entire code of conduct is different document quality policy shouldn’t be a substitute for comprehensive conduct standards for employees. The Quality Policy should be; short and sweet, avoid so many paragraphs, easy to understand and incorporate it into the daily work. The quality policy should reflect the “WHY” of the organization, The QMS documents should explain “HOW” it can be achieved.