cGMP-Compliant Stability Programs
Stability is a critical quality attribute, and a well-designed stability program is a vital component of regulatory submissions and post-approval studies for pharmaceutical drug products. Stability testing of pharmaceutical products provides data about how the quality of a drug product or substance changes over time when exposed to environmental factors such as humidity, temperature, and light. Stability studies also establish recommended storage conditions, testing intervals with bracketing and matrixing designs, and expiration dates.
An experienced CDMO partner who offers flexible storage conditions, effective program management, robust analytical testing capabilities, and an in-depth understanding of regulatory standards is essential to the success of a stability study. Pharmaceutical stability testing is an integral part of Avomeen’s CMC support services, and our expertise extends from method development and validation to clinical stability and release testing. We offer pharmaceutical stability testing in compliance with International Conference on Harmonisation (ICH) Q1A-F requirements for IND, ANDA, and NDA approvals for FDA regulated human drug products, as well as NADA approvals for Veterinary International Conference on Harmonization (VICH). We also offer storage conditions and protocols per the ICH stability requirements based on specific Zone designations. Our Ph.D.-led teams of chemists will develop a stability study protocol and program to meet your national and regional regulatory needs.
24/7 automated monitoring of stability chambers, equipped with back-up generators.
Development and validation of stability indicating analytical methods for entire product portfolios.
Proven success in delivering results for complex and analytically challenging APIs and drug product matrices.
Comprehensive Pharmaceutical Stability Testing Capabilities
We work with our partners to build comprehensive stability programs for drug substances and products that include the characterization of impurities, degradants, and changes in physiochemical characteristics, such as dissolution profiles, disintegration, friability of solid dose products as well as viscosities and rheology of topical gels and creams. Testing can be performed in ambient temperature, intermediate conditions, accelerated conditions, and long-term storage conditions. Additionally, we can support commercial stability studies with cGMP storage following conditions relevant to expiration dating of drug products.
- ICH stability testing services
- Forced degradation studies
- Real-time & long-term stability
- Accelerated stability
- In-use studies
- Beyond-use stability
- Formulation evaluation stability
- Follow-up stability testing
- Freeze thaw stability studies
- Stress stability testing
- R&D stability testing
- Finished product release
Drug Substance & Drug Product ICH Q1A-Compliant Storage Conditions:
- 25°C ± 2°C/60% RH ± 5% RH
- 30°C ± 2°C/65% RH ± 5% RH
- 40°C ± 2°C/75% RH ± 5% RH
- 5°C ± 3°C
- -20°C ± 5°
Pharma Stability Programs Support Various Regulatory Filing Pathways
Drug product submission applicants benefit from the resources made available by a CDMO partner. Our consultative team has the depth of regulatory and scientific knowledge necessary to prepare an effective CMC section of a regulatory submission, which includes stability data. We have experience supporting a variety of regulatory filing pathways, including:
- IND (505 (b)(1)
- NDA (new drug application)
- NADA (new animal drug application)
- 505(b)(2) Pathway (new chemical entity)
- ANDA (505(j) Pathway (generic products)
- OTC (monograph-based or IND-based)
Explore a CDMO Partnership to Support Your Regulatory Filing
Avomeen’s CMC experts can enhance the quality and efficiency of your regulatory filing and meet agency expectations. Our leaders and scientists have decades of CMC experience, and stay up-to-date with regulatory guidance and requirements. With a proven track record of providing comprehensive and complete CMC support for successful regulatory applications, our commitment to applying our scientific expertise is evident. Get in touch with an expert to explore a partnership with Avomeen.