Tag Archive: Guidance

Translating Study Reports – A GLP Draft Guidance

April 26, 2024 || LeAnna Pearson
Introduction: In a global community, studies are often conducted by testing facilities located outside of the United States of America, including countries such as Brazil, China, India, and Japan.  The final test reports and accompanying documentation require translation from the facility’s native language to English when performing the testing.  All…

Compliance: Framing Success Utilizing PIC/S and EU GMP

November 21, 2023 || LeAnna Pearson
Introduction PIC/S was founded in 1995 as an extension of PIC  (Pharmaceutical Inspection Convention).  They are a non-binding cooperative arrangement between 56 different Regulatory Authorities.  Just seeing the number 56 does not have the same impact as seeing the map below and understanding the true global reach of PIC/S.  Their…

Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline

November 20, 2023 || Rosario Hughes-Kielty
To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality Risk Management (QRM) principles have emerged as a key strategy in achieving this goal. QRM details a comprehensive evaluation of risks associated with both patient…