QUALITY ASSURANCE (QA)

Over recent years, quality in the pharmaceutical industry has become the focal point and emphasis. Guidelines and practices have been globally harmonized to a large extent. The Pharma industry is one of the most regulated sectors and has come under scrutiny leading to a self-regulation and the introduction of stringent compliance rules across the different functions such as pharmacovigilance and quality. This increases awareness is represented by the appearance of several definitions setting the standards of quality related to the manufacturing and delivery of medicine to patients. Having a solid Quality Management System in place and guidelines for employees such as SOPs, regular training on current GSP and GDP, and an advance CAPA system are all necessities for companies striving to achieve the desired outcome of treating patients with medicine that has the highest global quality possible.

Here at Genpharm, we believe that quality is at the core of everything we do. Where we aim every day to reach the highest standards of quality in every task and project we work on.

Considering that we are mainly operating in the Rare Disease and Specialty areas, it is crucial to have a robust and reliable quality system with which every single employee is made familiar. Nevertheless, for any system to perform, the quality and the commitment of the of people running it is crucial. Through the combined efforts of all the team at Genpharm in the entirety of its functions, the staff is working to provide patients their medicine in a way that ensures the best Quality, Efficacy, and Safety status based on the latest regional and global quality standards.

We at Genpharm strive every day to make sure all our team members are highly qualified, experienced and trained on all needed tasks to meet the standards. We ensure that our job responsibilities must be well explained and understood. But most importantly, we are always highly motivated knowing that our role in delivering high-quality medicine to all of our patients is fundamental and has the power to impact patients and their family in their daily lives. This is the highest purpose enshrined in Genpharm’s values that are:

Patient Care: At Genpharm, patients are at the center of everything we do. Improvement of patient care is a dynamic process and must be uppermost in the minds of medical care personnel. Development and sustenance of a patient-sensitive system are most critical to achieving this objective. It is also very important to pay attention to quality in every aspect of patient care, both medical and non-medical.

Accountability:  The importance and significance of accountability in Genpharm cannot be overstated. Accountability is the responsiveness, responsibility, answerability, and evaluation. We trust that accountability is much more than that and must go to the core of the business activity

Innovation: Every innovation strategy needs highly skilled and motivated people to implement it. Giving employees the chance to lead or participate in high-profile innovation initiatives is important to developing a strong innovation culture pushing to achieve a better way to serve our patients with better quality. We at Genpharm care to create a failure-friendly environment, establish ‘Learn from the top’ with senior executive participation in innovation projects, and set up internal communities of interest.

Integrity: Honesty and trust are the core of integrity. Genpharm employees abide by their values in treating their coworkers, clients, and patients with honor and truthfulness. Our Employees are trustworthy and dependable. They are principled and can be counted on to behave in honorable ways.

Teamwork: At Genpharm we believe that each employee brings a different set of skills, experience, and expertise. It is important that the company benefits from this diversity. The sum of the team is more important than the sum of one individual. Cross-functional exchanges and teamwork are encouraged at Genpharm.

Genpharm is committed to promoting the culture of continual quality improvements and the philosophy of getting the job done “Right the First time”. By promoting the quality management systems and ensuring implementation is achieved by internal auditing, management review, corrective and preventative actions.

We commit to being always seen as the partner of choice, offering best added-value services to both clients and patients.

 



 

 

Written by

Karen Sultan

Quality Assurance and Regulatory Affairs Associate