ICH Q9 Revision 1: Updates to Enhance Quality Risk Management in the Pharmaceutical Industry and a Pathway to a Robust Contamination Control Strategy
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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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Annex 21 – Are we on track and is there an impact?
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Annex 21 – Are we on track and is there an impact?

Annex 21 went into effect on August 21, 2022. It’s time to check that processes and procedures have not fallen short of the actual requirements...

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Supply Chain Resilience
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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
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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
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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On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).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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The Future of FDA Regulatory Inspections:   
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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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Bridging the Gap: Role Clarity, Skill Investment, and the Battle Against Drug Shortages 
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Bridging the Gap: Role Clarity, Skill Investment, and the Battle Against Drug Shortages 

As advancements in medical science continue to expand the array of available treatments, the demand for pharmaceuticals has surged.  This surge has caused an alarming...

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Reflecting Again on GMP Requirements for Marketing Authorization Holder
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Reflecting Again on GMP Requirements for Marketing Authorization Holder

In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This...

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