Tag Archive: Guidance

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…
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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…
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