PJI Biotech 

PJI Biotech

  Strategic Quality and Regulatory Management Consulting

Blog

China issues the rule of accepting overseas clinical trial data of drugs

Posted on October 26, 2018 at 12:45 AM Comments comments (0)
The China National Drug Administration issued the Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs (Principles) on 10 July 2018, which standardize the rule of accepting the overseas clinical trial data of drugs. According to the Principles, overseas clinical trial data provided by applicants for drug registration in China shall be complete, correct, true and traceable. The process of obtaining the overseas clinical trial data shall comply with both the Go... Read Full Post »

Out of Specification (OOS) Results and Trending Program

Posted on October 26, 2018 at 12:45 AM Comments comments (0)
MHRA guidance for handling OOS results was recently updated and is available on MHRA website. FDA guidance for handling of OOS was initially issued in 1998 as draft and was finally issued in 2006. MHRA guidance on handling OOS results was initially published in 2013 and was updated to add handling of microbiological OOS. MHRA guidance is complementary to FDA guidance and provides flowcharts for OOS investigations. There are 3 phases of an OOS investigation. During Phase 1 and 2, investigation i... Read Full Post »

Emerging FDA Drug Inspection Trends in 2016

Posted on January 31, 2017 at 9:55 AM Comments comments (1)
Regulatory observations (483) over past years has forced quality executives to be on their toes. The top 5 key issues for 2016 are related to inadequate procedures and investigations, laboratory controls and aseptic processing. 1. Procedures not in writing and fully followed. 2. Lack of scientifically sound laboratory controls. 3. Thorough investigation of discrepancies and failures. 4. Absence of written procedures. 5. Deficient environmental monitoring system. How can these be preven... Read Full Post »