
ICH Q9 Revision 1: Updates to Enhance Quality Risk Management in the Pharmaceutical Industry and a Pathway to a Robust Contamination Control Strategy
Originally issued in 2005, ICH Q9 laid down principles and examples of tools for QRM that can be applied throughout the product lifecycle. It was...
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Translating Study Reports – A GLP Draft Guidance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,...
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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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Supply Chain Resilience
Most people take for granted that medication prescriptions will be ready at the pharmacy counter and available for pick up when ordered to get themselves...
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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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Remote Regulatory Assessments – Q&A: Here to Stay
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs). The FDA has...
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FDA Quality Management Maturity Program
Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the...
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The Future of FDA Regulatory Inspections:
The Office of Regulatory Affairs (ORA) at the U.S. Food and Drug Administration (FDA) is currently buzzing with activity and exciting developments. Here's a snapshot...
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Compliance: Framing Success Utilizing PIC/S and EU GMP
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....
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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...
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