As of August 2017, the FDA has released 225 warning letters since the beginning of the year. The summary below reveals trends and patterns in FDA's recent inspection and enforcement activity.Continue Reading
Inadequate standard operating procedures (SOPs) are one of the most frequently cited causes of many deficiencies and observations found in Forms 483 and Warning Letters. And while specific SOP issues can often be traced back to poor communication, monitoring, and/or enforcement, a poorly written SOP can quietly grow into a host of other major compliance problems.
A well-crafted SOP offers clear direction and instruction specifically designed to avoid deviations––an absolute necessity for maintaining compliance and delivering quality products.Continue Reading
The release of the ICH Guideline for Good Clinical Practice (E6 R2) in November of 2016 has, for the first time in over a decade, put new guidelines and regulations in front of clinical trial Sponsors and Investigators.
ICH E6 R2 brings a new set requirements and a particularly intense focus on Clinical Trial activities to ensure higher quality studies. These new regulations have a major impact on CROs, software vendors, auditors, and quality professionals alike.Continue Reading