Overcoming Impurity Analysis And Regulatory Compliance Through Smart Supply Chain Management

Accurate analysis ensures the quality, safety, and efficacy of drug products that reach the marketplace. However, method development and validation regulations are extensive and stringent, and they are continually evolving as new therapies and analytical technology advancements are introduced. CDMOs can help their customers reach the market sooner if they anticipate evolving compliance requirements, and then implement corresponding method development and validation strategies. Those strategies should include a robust plan for supply chain security.

Evolving Regulatory Requirements

Current Good Manufacturing Practice (cGMP) shows us that the pharmaceutical industry, while highly conservative, is far from static. In their efforts to ensure continued safety and efficacy of APIs entering the consumer market, regulatory agencies are raising the standards for analytical testing. To meet these standards, - CDMOs are generating more high-value information through advances in the accuracy and precision of existing instruments, as well as the portability and high-throughput capabilities of many analytical techniques.