How to Assess the Quality of a Pharmaceutical Medical Device?
How to Assess the Quality of a Pharmaceutical Medical Device?
Health has always been a central concern in our lives. Everyone seeks to preserve it and improve it. To achieve this goal, numerous technological and scientific advances have been implemented and continue to be developed.
Pharmaceutical medical devices play a key role in treating many diseases or, at the very least, slowing their progression. To deliver such benefits, quality is essential. This naturally raises an important question: how can the quality of a pharmaceutical medical device be assessed?
Product Development
During the product design and development phase, multiple tests are carried out to continuously verify product quality. This means that each project is closely monitored by a dedicated team, from the very beginning through to commercialization.
This team is composed of experts in the field and is supported by modern, qualified equipment. Several methods and processes are implemented to ensure high quality standards, including:
- Validation of analytical methods after development.
- Transfer of validated analytical methods.
- Use of climatic chambers for product storage under conditions recommended by the ICH and the World Health Organization (light exposure, humidity, temperature, etc.).
- Stability studies to determine optimal storage conditions and establish product shelf life.
- Final quality control before batch release for commercialization.
- Identification and characterization of any unknown substances.
For storage purposes, the ICH program ensures appropriate conditions through continuous monitoring. Recording systems connected to safety alarms help guarantee product stability. All parameters are carefully calibrated according to the volume of the climatic chamber.
In terms of equipment, a wide range of technologies enables advanced control. Every effort is made to detect even the slightest deviation in product composition that could compromise quality. Patient health and safety depend on it.
As a result, a pharmaceutical medical device that is highly regulated and thoroughly controlled as described above can achieve an exemplary level of quality.
Unither Pharmaceuticals
This is precisely the approach that Unither Pharmaceuticals follows rigorously in order to guarantee reliable, high-quality pharmaceutical products. For more than 30 years, we have been manufacturing pharmaceutical products as a contract development and manufacturing organization (CDMO), responding to the specific needs of our customers.
Beyond manufacturing, innovation and development are also at the heart of our activities. Our production sites are regularly inspected by various international health authorities. Both our processes and facilities are assessed to ensure full compliance with current regulations.
We are continuously striving to improve and to provide high-quality services to our customers. To achieve this, we remain at the forefront of technology and pursue ongoing innovation, with a particular focus on pharmaceutical packaging in order to deliver solutions tailored to each customer’s needs.
Health is a critical field, and we are deeply committed to doing everything possible to ensure consistently high quality across our products and services.