Blog Post

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...

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Blog Post

Patient Safety is the Perspective for Prevention

When I first started writing this blog, the subject was remediation for regulatory inspections. But, as I progressed through the authoring of this blog, I...

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Blog Post

Patients emerge as the ultimate beneficiaries of Aseptic Processing Technology advancements

Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical...

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