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EU GMP Annex 1 Compliance: Global Requirements & PIC/S Alignment

The 2023 revision of EU GMP Annex 1 reset the global standard for sterile manufacturing. It expands the guidance, tightens contamination-control expectations and aligns requirements...

Translating Study Reports – A GLP Draft Guidance

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,...

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

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...