30. November 2021
Qmedics has obtained the Good Manufacturing Practices (GMP) certificate for its quality control, cleanroom facility and medical device manufacturing activities at its Swiss-based facility in Zürich- Flurlingen in November 2021
Qmedics has received the certification from the Regulatory Authority of Brazil, ANVISA (Agência Nacional de Vigilância Sanitária, Brazilian Health Surveillance Agency) following an inspection and audit of our quality system, cleanroom facility and manufacturing. This certification has been achieved without any findings.
I am very pleased that Qmedics AG has been able to achieve the GMP certification. A GMP certification in general is granted to companies whose production facilities demonstrate a high degree of quality and consistency in their manufacturing procedures.
Prof.Dr.med Patteet Anita CEO of QMedics attributed this accomplishment to the hard work of Qmedics production, R&D and Quality team and their dedication to ensure that Qmedics cleanroom, production facility, quality system and R&D design history files complies with the most stringent standards. This certification enables us to continue in our global growth strategy and fulfill contracts in the Brazilian and EU market.
Given the other challenges surrounding the COVID – 19 Pandemic, it was stated not so much request were there for GMP certifications (Current Good Manufacturing Practices)
certificate in 2021. However, Qmedics as an OEM and Legal manufacturer of medical devices who prioritize safety, quality, product integrity, and operational excellence was determined to complete the GMP submission with a certification end 2021.
Quality management is an integral philosophy for consistently improving the quality of manufactured medical device products. Together with the development of our new product portfolio (SDS Family EXIST, FALCOR and DRACO) we took on the challenge to adapt our quality and production management system to become compliant with the GMP requirements that will bring an enhancement in product and production safety what serves at the end the wellbeing of our patients.
For Qmedics the implementation of GMP requirements is enormously important for the manufacturing and quality process because it ensures a level of quality, safety, purity, and strength in any products that are released to the public.
The implementation of the compliance with the GMP took Qmedics practically a full year starting with:
- Taking the existing quality system that ensures every Qmedics product has established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness up to the cGMP level. Especially given attention to the assessment and mitigation of risk, and the change control and CAPA processes.
- Updating the designing and developing processes of Qmedics products and associated manufacturing processes to ensure that the product consistently attains a predefined quality at the end of the manufacturing process.
- Implementing systems to maintain compliance with Current Good Manufacturing Practices and Quality System regulations
Now Qmedics operates a state-of-the-art Good Manufacturing Practice (GMP) production facility.
We are proud to be one of the few medical device legal and contracted manufacturers in Switzerland to have received this certification,” said Prof.Dr. med. Patteet Anita CEO of Qmedics.
Going further with the commend-: “This certification will allow Qmedics to produce our own state of the art product portfolio under the highest quality regulations, and facilitate the business in EU, middle east and Brazil on one hand – but on the other hand we can be seen as a perfect partner for contracted manufacturer for medical devices.