With quality assurance being a critical aspect of pharmaceutical manufacturing and distribution, we sat down with John Scicluna, European Responsible Person at Essential Pharma, to gain insights into his role and the importance of maintaining high standards in the industry. In this Q&A, we explore the challenges of consistent quality management, the integration of innovative technologies, and the personal satisfaction derived from contributing to patient and public health.
- Can you expand on your role within the Quality Team at Essential Pharma? At Essential Pharma I oversee quality in areas of manufacturing and distribution. This involves a series of smaller tasks which ultimately lead to upholding the required level of quality, from the creation and implementation of processes, reviewing of documentation, to performing audits. One of the routine activities which I am responsible for is contacting our distribution partners and scheduling onsite audits in line with a schedule that our team works on and approves beforehand.
- What is the importance of quality in the manufacturing and distribution process of medicines? Quality is important in all aspects of life. When you think about quality time with friends and family, it means that the time was well spent – the same applies to medicines. Quality when applied to medicines means that they achieve their intended use and produce the desired effects in patients.This can be achieved if all aspects of manufacturing and distribution have quality integrated into them. That is the only way we can ascertain that a medicinal product is of the required quality.Taking it a step further, quality in medicines is even more important because we are dealing with vulnerable patients with the expectation of getting better after taking the medicine. It is a fundamental aspect of delivering safe and effective treatments to patients, and reducing the burden on their lives.
- Can you touch on any of the challenges and complexities in maintaining consistent quality and compliance activities? The significance of quality needs to be embraced by all employees within a company. It is not only the responsibility of the Quality team. It requires a collective effort. One of the biggest challenges a Quality team faces in any organization is ensuring that all employees adopt this quality-orientated mindset across everything they do, irrespective of the department in which they work. At Essential Pharma we have worked very hard to build and foster a culture that encourages and celebrates this.Another particular challenge is the consistency of documentation we receive from partners. Unfortunately, while in-house documentation can be controlled, we have little control over documentation we receive from external partners, which can sometimes present difficulties primarily due to language barriers. However, our team embraces this challenge as being all part of working in a global company.
- What are your plans to integrate recent innovations or technologies into your quality assurance process to improve efficiency? In recent years, digital solutions have been developed to the extent where they can now make a company’s pursuit of quality easier and more efficient. These solutions greatly reduce the manual input of data, centralize documentation, improve process workflows and ease communication.The implementation and integration of digital solutions is definitely the way forward to improve both compliance and efficiency.At Essential Pharma we have implemented a rigorous online training program which organizes training materials and records, notifies trainees of pending training, and gives us all the training metrics and outcomes, ensuring a more seamless and efficient quality assurance process.
- How do you approach risk management in quality assurance, especially when dealing with highly specialized pharmaceuticals? The ultimate risk for pharmaceutical companies is the impact on patient safety and public health. The approach to risk assessment should always put patient safety first. This is done by assessing each event and determining how this will eventually impact the patient.The process of identifying, evaluating, and mitigating recognised risks is more extensive in Pharma than in many other industries, simply because medicines are not like any other product. There is an innate need for them because they are intended to improve a patient’s health. If this cannot be achieved, or even worse, the patient’s health deteriorates because of the medicine, then that is a critical failure.
- What is the most satisfying part of your job? My first response would be that I enjoy seeing all the pieces come together when the quality system and processes are functioning as they should. But ultimately, I think the greatest satisfaction comes from knowing that, however small, you are playing a part in preserving and improving patient and public health.
- What is it like working at Essential Pharma? It may sound like a cliché, but at Essential Pharma there is a sense of belonging. It may be because the company is quite small when compared to big pharmaceutical companies, but working at Essential Pharma is not simply doing your job and that’s it. Here people value your presence, ideas, hard work, and efforts.
