These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.
By Michael Rowe, director, DSCSA/Serialization Services, Two Labs
Serialized data exchange, enhanced verification, and tracing, oh my! Many companies are still unprepared for full DSCSA implementation in November. Is your company one of them? Here are the important actions to take now.
Article |
By Donald DeCou and Matthew Woods,West Pharmaceutical Services, Inc.
Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.
