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  • 7 Steps To Properly Navigate An Event Investigation
    7 Steps To Properly Navigate An Event Investigation

    A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.

  • Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing
    Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing

    Water is the single largest quantity raw material used in pharmaceutical manufacturing. Water is used in all facets of manufacturing, from preparing equipment to manufacturing the final commercial product.

  • An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling
    An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling

    Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.

     

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More From Pharmaceutical Online Videos

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7 Steps To Properly Navigate An Event Investigation 7 Steps To Properly Navigate An Event Investigation

A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.

Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing

Water is the single largest quantity raw material used in pharmaceutical manufacturing. Water is used in all facets of manufacturing, from preparing equipment to manufacturing the final commercial product.

An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling

Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.

 

How To Establish An Aseptic Gowning Qualification Program How To Establish An Aseptic Gowning Qualification Program

Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.

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TITLE SUMMARY DISPLAY

  • 7 Steps To Properly Navigate An Event Investigation

    A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.

  • Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing

    Water is the single largest quantity raw material used in pharmaceutical manufacturing. Water is used in all facets of manufacturing, from preparing equipment to manufacturing the final commercial product.

  • An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling

    Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.

     

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

7 Steps To Properly Navigate An Event Investigation 7 Steps To Properly Navigate An Event Investigation

A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.

Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing

Water is the single largest quantity raw material used in pharmaceutical manufacturing. Water is used in all facets of manufacturing, from preparing equipment to manufacturing the final commercial product.

An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling

Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.

 

More From Pharma Contributing Editors