Skip to main content

Quality control vs quality assurance in a pharmaceutical setting

Janis Slisans our consultant managing the role
Posted by Janis Slisans
Published on 27 July 2022

Quality control and quality assurance are often used interchangeably in pharmaceutical settings. This is because they both refer to different aspects of quality management and meeting the high expectations and demands of customers. Quality control and quality assurance jobs are all about ensuring the medication has been manufactured correctly and is safe to use, as well as having its desired effect.

Without these two functions of quality management, a pharmaceutical organisation would struggle to achieve consistency in its output. Quality control and quality assurance are highly important and contribute to productivity and the overall success of an organisation’s products. Below, we take a closer look at quality control and quality assurance.

blue gloves on hands holding a syringe

What is the difference between QC and QA?

The key difference between quality control and quality assurance lies in the purpose and objectives of the two functions. They’re both crucial to the production and release of different medical products. The aim of quality control in the pharmaceutical industry is to verify and test the medicine at various stages of production, to ensure every product is of the highest quality.

Quality control also involves identifying any defects in products and fixing these problems with corrective techniques and measures. It’s the process of inspecting and approving products to ensure they meet the required customer and regulatory standards. Quality control is an important part of quality management in a pharmaceutical setting.

On the other hand, quality assurance is the process of making sure quality requirements have been fulfilled. Quality assurance aims to prevent mistakes and defects, as well as manage quality through defining processes, establishing standards and developing guidelines for better quality management. So, quality assurance is focused on the process while quality control revolves around the product.

Team vs individual

There’s also a contrast between how quality control is carried out compared to quality assurance. Quality control is often the responsibility of certain individuals in a pharmaceutical organisation . These duties would be carried out by quality control specialists, who undertake product testing and process validation. These professionals will be specialists in troubleshooting errors in medical products and making sure they comply with legal standards.

Quality assurance, on the other hand, involves an entire team with each member responsible for QA activities such as documentation, planning, project auditing and other forms of quality assessment. There’s also the quality management system, which is normally overseen by the leadership team.

How to thrive in a pharmaceutical setting

Whether you work in quality control or quality assurance, you’ll still need to have a clear understanding of how to succeed in a pharmaceutical setting. Firstly, make the most of any training and development opportunities that come your way. Many pharmaceutical companies offer their employees robust training and personal development programmes to ensure they keep learning and remain engaged in their work.

Also, make sure you’re continuously showing your value. As a QC or QA professional, you should be overcommunicating about projects and accomplishments. For example, if there are any medical products you have successfully fixed, share the results with your manager and wider team.

What is the future of quality control and quality assurance?

The future of quality control and quality assurance in pharmaceuticals is likely to be dominated by artificial intelligence, automation and digitisation. According to research by McKinsey , there have been several developments by pharmaceutical and MedTech companies to improve quality assurance with new digital technologies and analytical tools. This means quality control specialists and quality assurance teams will need to adapt to new software and functionalities, as the pharmaceutical industry becomes increasingly digital. There will always be a need for quality management, but in the future, it will likely be a much more streamlined process.

Are you looking for a new role in a pharmaceutical setting?

There’s a wide range of roles in the pharmaceutical industry. If you want to move your career forward in pharmaceuticals, whether that’s in quality control or quality assurance, Quanta is here to help! Since 1992, our team has been providing quality recruitment solutions. We’re determined to help place our candidates in the best roles. We take the time to understand the needs of clients and candidates so they always receive the best possible service. So, if you’re looking to start a new role in GA, get in touch with our compliance and quality assurance team for more information.