How We Incorporated PDCA Cycle in MVS Pharma: In Quality management, there are several important principles that are core and define it. Good QM involves establishing systems, processes, and principles that enable businesses to achieve high-quality results effectively. A fundamental principle of QM is the constant improvement of processes, services, and products. Methods such as Plan-Do-Check-Act (PDCA) also known as Deming’s wheel are often employed to identify areas of improvement, implement changes, and monitor results for further development. This is exactly what we wanted and achieved at MVS Pharma. With special thanks to our Quality Management and team representatives who spend many hours working on our QMS using all their knowledge and professional experience. We always aim to provide top-quality and well-checked products using all the necessary tools for that purpose including PDCA.
When faced with the recent shortage of amoxicillin for children in Germany, MVS Pharma recognized an opportunity to incorporate the PDCA cycle into our quality management system to help alleviate this issue. Our aim was to identify a reliable supplier, ensure the highest standards of quality, and provide a well-checked and efficient solution for the market. Here’s how we successfully implemented PDCA in our process:
Plan: Identifying the Problem and finding a solution
The first step was to thoroughly understand the problem – the shortage of amoxicillin in Germany. This scarcity created a pressing need for alternative suppliers, and our team began by identifying potential manufacturers. India stood out as a leader in pharmaceutical production, so we focused on finding one of the best manufacturers that could meet the strict European quality standards.
We collected information on their production capabilities, certifications, and compliance with Good Manufacturing Practices (GMP). The plan was to ensure that the selected supplier could provide amoxicillin that met both regulatory requirements and customer expectations. Data collection and risk analysis were essential in this phase, as we aimed to choose a partner capable of delivering the best product.
Luckily we have a team in India and the manufacturing facility was checked in person by MVS team members.
Do: Testing and Sample Evaluation
Once we had identified a reputable manufacturer, the next step was to test their product. We ordered samples of amoxicillin and sent them to a specialized laboratory in Italy for thorough testing. This trial was crucial to ensure that the product not only met our quality standards but also complied with the necessary pharmaceutical standards.
During the Do phase, we closely monitored how the manufacturer adhered to quality requirements, verifying every stage of the production process. This allowed us to confirm that they followed the exact specifications needed for safety and efficacy.
Check: Analyzing Results – PDCA Cycle MVS Pharma
The Check phase is where we reviewed the laboratory results from Italy. This was a critical stage, as it provided the data needed to evaluate the quality and effectiveness of the amoxicillin samples. We checked the antibiotic for consistency, purity, and potency, comparing the results against the strict requirements of both the European Union and our internal standards.
By thoroughly reviewing the lab reports, we were able to verify the quality of the product and ensure it met the high standards necessary for children’s medications. The evaluation in this phase was pivotal in determining whether or not to move forward with the supplier.
Act: Implementing the Solution
Once the amoxicillin passed all tests and quality checks, we moved into the final stage—Act. Based on the successful results, we decided to formally partner with the Indian manufacturer and to establish future working relationship with them. Our goal is to begin placing larger orders to address the shortage in Germany. This stage also involved implementing lessons learned during the process, allowing us to better our approach to supplier selection and product testing for future needs.
PDCA in Action: Our Commitment to Quality – PDCA Cycle MVS Pharma
Using the PDCA cycle, MVS Pharma was able to effectively respond to a critical need in the pharmaceutical market. Our Quality Management System (QMS) and dedicated team worked diligently to ensure that every step, from identifying the manufacturer to testing the final product, followed a rigorous process of continuous improvement.
Thanks to PDCA and our commitment to quality, we can provide the German market with a reliable supply of well-checked amoxicillin for children, fulfilling our mission to deliver safe, high-quality pharmaceutical products.
At MVS Pharma, we pride ourselves on using the best tools and processes, such as the PDCA cycle, to guarantee excellence in everything we do.
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MVS Pharma GmbH will soon be launching an omega-3 dietary supplement onto the European market that has been developed for the highest quality standards in terms of oxidation avoidance and therefore, the greatest bioavailability. In addition, in vitro studies are currently underway at the University of Ulm, in which Professor Dr. Rüdiger Groß tested a patented mouth and nose spray (Virudol) that can eliminate various flu viruses based on natural substances. In addition, MVS has a wholesale license and has specialized in sourcing much-needed medicines such as Amoxicillin, Salbutamol, etc. from India through its local branch with a focus on local quality and safety testing, compliance with international GMP regulations and the highest quality level of user security (examples of local language brochures, identical units of measurement, batch control and full tracking, etc.).
