ICH Stability

We will develop a robust and regulatory compliant stability program based on ICH guidelines and the specific requirements of your product, minimizing consumption of your clinical supply.

We continue to evaluate and expand current testing capabilities to support our clients growing needs. We can simplify your supply chain and reduce the associated risk of cold-chain shipments and the added costs of transferring your analytical methods to a third-party laboratory.

Our Stability Testing Services

Our validated storage conditions include:

  • -80°C
  • -20°C
  • 2-8°C
  • 25°C/60%RH
  • 30°C/65%RH
  • 40°C/75%RH

 

We have the capability to perform non-GMP and cGMP photostability studies for drug substance and finished product.

  • Photostability protocol development utilizing ICH Q1B stability guidelines
  • 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

 

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 over-sized backup power generators, a validated building monitoring system with redundant alarms and integrated UPS technology.
 

Our integrated teams will work together to provide you with one-on-one personalized attention and streamlined communication throughout your entire stability study. We will 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.
 

 

Our dedicated team of specialists will be happy to discuss our ICH Stability Services with you. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

The trusted partner for global integrated CDMO services.

When it comes to sterile fill-finish and lyophilization manufacturing, you can rely on us.

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