Drug stability studies under real conditions of use
In-use stability studies are essential in the pharmaceutical sector, especially for products that require specific handling or preparation by the patient. These studies guarantee that the product maintains its effectiveness and safety throughout its shelf life under real use conditions.
In-use stability services at Netpharmalab
- Simulation of Real Conditions of Use: At Netpharmalab we carry out studies that accurately replicate the real conditions of use of the product, as detailed in the instructions for use or in the leaflet. This includes the simulation of repeated cycles of opening and closing multi-dose containers, as well as reconstitution or dilution processes, imitating the actions that a patient would carry out. We evaluate how these activities can affect the stability of the product, its effectiveness and its safety.
- Comprehensive Evaluation Over Time: Our studies cover from the initial release of the product to the end of its useful life. This approach allows us to monitor and evaluate the stability of the product throughout its life cycle, ensuring that it remains within the quality and safety standards established for patient use.
- Advanced Facilities with Climatic Chambers: We have state-of-the-art climatic chambers, calibrated and qualified, that recreate a range of environmental conditions. These include different combinations of temperature and relative humidity, such as 25ºC/60% RH, 30ºC/65% RH and 30ºC/75% RH, to simulate the specific conditions of use of the product. These cameras are essential to ensure that studies accurately reflect the environment in which the products will be used.
- Rigorous Analysis and Reporting Procedures: At Netpharmalab, we meticulously handle every stage of the study, from writing protocols to performing analyzes and preparing reports and stability tables. Our detailed approach ensures that every step of the process is carried out according to Good Manufacturing Practices (GMP), providing complete and reliable documentation of results.
- Commitment to Quality and Regulatory Compliance: We focus on maintaining the highest technical rigor and complying with all applicable regulations. Our team of experts works tirelessly to ensure the validity and reliability of the studies, which is essential to confirm that pharmaceutical products maintain their stability and properties under real-world conditions of use.
Our commitment
We are dedicated to ensuring that every pharmaceutical product tested in our in-use stability studies meets the highest standards of quality and safety. At Netpharmalab, we combine technical expertise, advanced facilities and a rigorous focus on quality to provide exceptional services. Our objective is to be a strategic ally in the industry, offering confidence and security to our clients in the management and evaluation of their products.
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