Process Validation You Can Trust
Before NDA filing, Asymchem works with customers on the process validation (PV) enabling work (pre-PPQ) that will optimize existing knowledge and deliver a robust commercial process. Using our extensive experience, we can ensure that the resulting process includes the starting material selection and justification, specification establishment and justification for intermediates, proven acceptable range (PAR) establishment for all process parameters, and CPP/KPP/CIPC identification.
During the PV enabling work we focus on impurities identification and their control — both process parameters and material attributes can affect product quality. Our proven template defines the timing and types of activities to guide the PV enabling work.
Underlying all the process activities are the analytical methods. Asymchem has strength in analytical method development and validation, and the analytical teams work hand-in-hand with the process teams to deliver reliable methods for confirming in-process controls (IPCs), intermediate and final product specifications, as well as stability of intermediates, drug substances, and drug products.
With 40+ successful project validations (including 140+ process steps) over the last 3 years, Asymchem knows the best path to take to fill in gaps in the process knowledge to lead to a successful regulatory filing, process validation, and ultimately commercial manufacture.
Comprehensive PPQ services to support NDA and commercial validation
- Process Risk Assessments documentation
- Process optimizations
- Establish proven acceptable ranges (PARs) and normal operating ranges (NORs) for all process parameters
- Establish critical material attributes(MAs) for starting materials, including specifications
- Conduct impurities fate and purge studies to establish specifications, for starting materials and intermediates specifications, and in-process controls (IPC)
- Establish robust impurity profiles for intermediates and final drug substance
- Establish critical process parameters (CPPs) and key process parameters (KPPs)
- Successful scale up and validation
- Protocols and final reports issued in support of all activities