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IMAGE TITLE SUMMARY DISPLAY

  • Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination
    Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

    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 foundational introduction to cleanroom microbiology discusses some of those aspects.

  • Developing Mobile Continuous Process Technology:  A Collaborative Innovation Case Study
    Developing Mobile Continuous Process Technology: A Collaborative Innovation Case Study

    In Part 1 of this two-part article, we explored the role of open collaboration in the future pharmaceutical manufacturing innovation. Part 2 provides a specific example of how such collaboration is already taking place, through a unique industry-academic partnership.

  • An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities
    An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities

    Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

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Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

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 foundational introduction to cleanroom microbiology discusses some of those aspects.

Developing Mobile Continuous Process Technology:  A Collaborative Innovation Case Study Developing Mobile Continuous Process Technology: A Collaborative Innovation Case Study

In Part 1 of this two-part article, we explored the role of open collaboration in the future pharmaceutical manufacturing innovation. Part 2 provides a specific example of how such collaboration is already taking place, through a unique industry-academic partnership.

An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities

Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

Beyond The FDA Guidance:  Practical Considerations For Quality Agreements Beyond The FDA Guidance: Practical Considerations For Quality Agreements

Much has been written in recent months about the FDA’s final guidance for industry, Contract Manufacturing Arrangement for Drugs:  Quality Agreements, issued in November 2016.  Recently, a thorough assessment of the guidance requirements and gaps was published on this website. (See FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) and Examining FDA's New Quality Agreement Guidance.)

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TITLE SUMMARY DISPLAY

  • Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

    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 foundational introduction to cleanroom microbiology discusses some of those aspects.

  • Developing Mobile Continuous Process Technology: A Collaborative Innovation Case Study

    In Part 1 of this two-part article, we explored the role of open collaboration in the future pharmaceutical manufacturing innovation. Part 2 provides a specific example of how such collaboration is already taking place, through a unique industry-academic partnership.

  • An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities

    Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

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 foundational introduction to cleanroom microbiology discusses some of those aspects.

Developing Mobile Continuous Process Technology:  A Collaborative Innovation Case Study Developing Mobile Continuous Process Technology: A Collaborative Innovation Case Study

In Part 1 of this two-part article, we explored the role of open collaboration in the future pharmaceutical manufacturing innovation. Part 2 provides a specific example of how such collaboration is already taking place, through a unique industry-academic partnership.

An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities

Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

More From Pharma Contributing Editors