Stability studies of pharmaceutical products under ICH guidelines
Stability studies are a key pillar in the development and approval of pharmaceutical products and must comply with established international guidelines, in particular by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The characteristics of ICH stability studies are set out in the ICH Q1A Guideline, which provides essential guidelines on the stability of pharmaceutical products, an area regulated in detail by this global organization.
ICH stability study services
- Compliance with ICH Guidelines: At Netpharmalab our stability studies are rigorously aligned with ICH regulations, especially Guideline ICH Q1A. This guarantees that pharmaceutical products are evaluated under the most demanding international standards.
- Adaptation to ICH Climatic Zones: We carry out studies that cover the different climatic zones defined by the ICH, from Zone I to Zone IVb. Each zone represents specific environmental conditions that influence drug stability. We use calibrated climate chambers to simulate these conditions and evaluate how they affect product stability.
- Versatile Climatic Chambers: Our facilities are equipped with a variety of climatic chambers, including 25ºC/60% RH, 30ºC/65% RH, 30ºC/75% RH and 40ºC/75% RH. These chambers allow us to carry out stability studies that cover a wide range of environmental conditions, as well as studies for products that require cold storage, with chambers at 5 ± 3ºC.
- Rigorous Protocols and Reports: We develop detailed protocols before beginning stability studies and maintain a thorough record and report of the results. Our team is in charge of preparing reports and stability tables, ensuring that all documentation complies with Good Manufacturing Standards (GMP) and applicable regulations.
- Focus on Quality and Regulatory Compliance: Our commitment focuses on technical precision, the quality of results and strict compliance with regulations. This ensures the validity and reliability of our stability studies, a critical aspect for the safety and effectiveness of pharmaceutical products.
Our commitment
At Netpharmalab we offer stability study services that meet the highest international standards. We understand the critical importance of these studies in the life cycle of a pharmaceutical product and strive to ensure that each analysis contributes to the safety and effectiveness of the final product. With our advanced technology and detailed focus on quality, Netpharmalab is positioned as a strategic and trusted partner in the pharmaceutical industry, providing essential services for product validation and approval in a global market.
Our goal is to ensure that each product we evaluate meets not only current regulations, but also maintains its stability and effectiveness under various environmental conditions, thereby providing maximum safety to patients and end users. Contact our team of experts to answer questions or request more information.
GMP
