As we celebrate Nd’s achievement of obtaining ISO 9001:2015 certification, we are delighted to share our success stories regarding our Quality Management System (QMS) and the Pharmaceutical Quality Systems (PQSs) that Nd has established for our clients.
When building a new Quality System or upgrading an existing one, the first question should be asked is: what is the purpose of this quality system?
Is it solely for the compliance purposes or is it to assure the quality of the product? While being compliant is the bare minimum, the ultimate goal and purpose of any quality system is to assure the quality of the product.
This is the fundamental reason why, at No deviation, we did not rush to set up a generic QMS and push for certification. Instead, we took the time to define what our company’s product is (in this case, the services we render for our clients), and then we sought to understand how the quality of that product would be impacted so that our QMS could focus on controlling the aspects critical to quality.
ISO 9001:2015 requires companies to understand the context of their organization in order to define the scope, processes, and level of effort required for their QMS. This principle also applies to the PQS under GMP governance, regardless of whether they adhere to FDA CFR, EU EudraLex, or any other GMP. It is important to note that there is no “one size fits all” approach when it comes to quality systems. Pharmaceutical manufacturers differ from one another in several ways, such as:
- Products: They have different requirements, complexities, and risks to patients. Hence, some products will require a more rigorous quality system than others.
- Activities and Responsibilities: These may include manufacturing, testing, development, and distribution, which could be under various internal and external organizations. Hence, the scope and process of the quality system will vary.
- Organizational Structure and Resources: A complex and heavy quality system that works well for a large multinational corporation with multiple branches and geographic locations may be a burden to a startup company with fewer resources and less experienced personnel.
- Jurisdiction: It is necessary to identify the applicable regulatory requirements as the basis for establishing the quality system. However, when the quality system is built genuinely to assure product quality, compliance comes naturally.
We take all of the above factors into consideration every time we establish and deploy a quality system for a client. It is never a simple task of merely deploying a set of documents. Instead, we work closely with the client’s team to truly understand their purpose for the quality system, their products, procedures, team structures, available resources, and desired compliance status. It is highly recommended that we collaborate with the system owner and users to mock up the procedures to validate their practicality, efficiency, and effectiveness. As even seemingly simple procedures, such as an approval flow, may require the involvement of various internal or external stakeholders and may be in different formats, i.e. wet signature or e-signature.
While setting up a quality system may sound like there is much to consider and test, it can be more straightforward than one may initially think. Understanding the fundamentals and applying a systematic approach can provide significant clarity throughout the entire process.
Last but not least, we are here to share our experiences to help you and the pharmaceutical industry enhance the quality maturity.
With 15 years of experience in the global pharmaceutical industry, predominantly in Process, CQV, Process Automation and Project Management, Shanshan has held both Consultant and End User roles. With increasing involvement in the GMP remediation and GMP audit projects, she has been building in-depth compliance knowledge as well as interaction with authorities globally.
