We can help you develop a robust program based on ICH guidelines for stability testing and the specific requirements of your product. We work with our clients to develop a regulatory sound, program to minimize consumption of your clinical supply. Trust LSNE to manage every aspect of your ICH stability program.
Adherence to ICH Guidelines for Stability Testing of Pharmaceutical Products
LSNE continues to evaluate and expand current testing capabilities to support our clients growing needs. We will simplify your supply chain and reduce the risk associated with cold-chain shipments and the added costs to transfer your analytical methods to a third-party laboratory.
ICH Stability Conditions
Our validated storage conditions include:
We have the capability to perform non-GMP and cGMP photostability studies for drug substance and finished product.
- Photostability protocol development utilizing ICH Q1B guidelines for stability testing
- Storing products in validated photostability chambers at the recommended light intensity
- Time point management, time point testing, and data reporting with quality oversight
- Final report
Protecting Your Product
In accordance with ICH guidelines for stability testing, all of our stability chambers and facilities are supported by redundant systems to safeguard your valuable drug product throughout the lifetime of the stability program. Our facilities redundancy consists of oversized back-up power generators, a validated building monitoring system with redundant alarms and integrated UPS technology.
Commitment to Quality
Our integrated teams will work together to provide you with one-on-one personalized attention and streamlined communication throughout your entire stability study. We can provide interim reports at each critical milestone of the program to support your IND submission, clinical trials or later stage NDA, ANDA, BLA or 505(b)(2) regulatory submissions.