Ongoing stability studies of active ingredients in drugs
Continuous monitoring of the stability of active ingredients is a fundamental pillar in the development and manufacturing of pharmaceutical products. This constant monitoring process, known as a stability assurance program or ongoing stability studies, is essential to ensure that active ingredients maintain their specifications, quality and effectiveness over time and under recommended storage conditions.
Ongoing stability services
- Ongoing Monitoring: At Netpharmalab we place special emphasis on the concept of ongoing stability. This involves constant monitoring of at least one annual production batch of the active ingredient to verify that it continues to meet the established specifications and maintains its quality and effectiveness throughout its reanalysis period.
- Annual Analysis and Special Situations: We carry out annual analyzes of the lots included in the ongoing stability program. Additionally, in situations of significant changes in manufacturing or the packaging and closure system, we include additional batches to evaluate stability under these new conditions.
- Calibrated and Qualified Climatic Chambers: We have calibrated climatic chambers that offer a controlled and precise environment to simulate storage conditions throughout the useful life of the active ingredients. Our cameras include configurations of 25ºC/60% RH, 30ºC/65% RH and 30ºC/75% RH, adapting to different study requirements.
- Detailed Protocols and Reporting of Results: We develop meticulous protocols before initiating ongoing stability studies. Our team is responsible for data collection and analysis, as well as the preparation of reports and stability tables, following Good Manufacturing Standards (GMP) and applicable regulations.
- Adaptability to Regional and Global Regulations: We recognize the importance of staying up to date with rules and regulations that may vary by region and country. At Netpharmalab, we ensure that our ongoing stability services are in compliance with the specific guidelines and regulations of each geographic location.
The ongoing stability program and studies at Netpharmalab reflect our commitment to the quality and long-term safety of pharmaceutical products. We understand the critical importance of constant monitoring for the integrity and effectiveness of active ingredients. With our detailed approach, advanced technology and adaptability to regional and global regulations, we strive to be a strategic ally in the pharmaceutical industry, providing stability monitoring services that ensure confidence and safety in our clients’ products.
Our goal is to ensure that each active substance evaluated under our ongoing stability program maintains its suitability for safe and effective use, even in the face of storage environment variations and challenges. Contact Netpharmalab, with our services clients can be sure that their pharmaceutical products are supervised with the highest rigor and technical competence, complying with the most demanding quality standards throughout their entire life cycle.