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  • FDA FY2019 Drug Inspection Observations And Trends
    FDA FY2019 Drug Inspection Observations And Trends

    A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug inspection data from CDER, which addresses drug inspections conducted in FY2019. The FDA published data from FY 2018 in September 2019 and we recently addressed that data; FY2019 data was published on Nov. 15, 2019. Here we examine data from FY2019, along with seven years’ worth of trends in drug GMP inspections.

  • Biocompatibility Considerations For Drug Delivery Devices — An Introduction To ISO 10993
    Biocompatibility Considerations For Drug Delivery Devices — An Introduction To ISO 10993

    Biocompatibility is an essential element for any pharmaceutical combination product. ISO 10993 is the standard for biocompatibility, and it is broken into various normative sub-standards from ISO10993-1 to -22 that focus on various assessments, considerations, recommendations, and approaches. 

  • Executing Signals And Responses In A Continued Process Verification Program
    Executing Signals And Responses In A Continued Process Verification Program

    Part 1 of this series provided an overview of CPV and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.

More From Pharma Contributing Editors

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  • Modular Cleanroom Panel Manufacturing Factory Tour

    AES Clean Technology Manufactures Modular Cleanroom Solutions. AES utilizes modular cleanroom systems in our design-builds and modular cleanroom  construction projects. The AES cleanroom wall system is made in our state of the art Suwanee, GA facility.

  • Introducing The Thermo Scientific™ HyPerforma™ DynaDrive Single-Use Bioreactor

    This Single-Use Bioreactor (S.U.B.) is the latest innovation in a long line of proven and industry-adopted Thermo Scientific S.U.B.s for cell culture, and the new dynamic in cell culture performance. The all new HyPerforma DynaDrive S.U.B. has an ergonomic cubical design, an innovative and efficient mixing system, and has been fully optimized for modern cell culture processes.

  • LEO Pharma Shares Production Data Across Europe With The PI System

    Poul Waagner Nielsen of LEO Pharma describes using the PI System as a central warehouse of production data for the people and manufacturing systems in their six factories spread across Europe.

More From Pharmaceutical Online Videos

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FDA FY2019 Drug Inspection Observations And Trends FDA FY2019 Drug Inspection Observations And Trends

A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug inspection data from CDER, which addresses drug inspections conducted in FY2019. The FDA published data from FY 2018 in September 2019 and we recently addressed that data; FY2019 data was published on Nov. 15, 2019. Here we examine data from FY2019, along with seven years’ worth of trends in drug GMP inspections.

Biocompatibility Considerations For Drug Delivery Devices — An Introduction To ISO 10993 Biocompatibility Considerations For Drug Delivery Devices — An Introduction To ISO 10993

Biocompatibility is an essential element for any pharmaceutical combination product. ISO 10993 is the standard for biocompatibility, and it is broken into various normative sub-standards from ISO10993-1 to -22 that focus on various assessments, considerations, recommendations, and approaches. 

Executing Signals And Responses In A Continued Process Verification Program Executing Signals And Responses In A Continued Process Verification Program

Part 1 of this series provided an overview of CPV and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.

Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers

The clock is ticking for state lawmakers to preserve an existing law that allows for prescription drug coupon usage in Massachusetts with an end-of-the-year deadline fast approaching. Drug manufacturers are anxiously awaiting this legislative action, as a ban on coupons would stick consumers with more of the cost when purchasing brand name drugs, which typically come with higher cost-sharing than generic equivalents.

More From Pharma Contributing Editors

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TITLE SUMMARY DISPLAY

  • FDA FY2019 Drug Inspection Observations And Trends

    A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug inspection data from CDER, which addresses drug inspections conducted in FY2019. The FDA published data from FY 2018 in September 2019 and we recently addressed that data; FY2019 data was published on Nov. 15, 2019. Here we examine data from FY2019, along with seven years’ worth of trends in drug GMP inspections.

  • Biocompatibility Considerations For Drug Delivery Devices — An Introduction To ISO 10993

    Biocompatibility is an essential element for any pharmaceutical combination product. ISO 10993 is the standard for biocompatibility, and it is broken into various normative sub-standards from ISO10993-1 to -22 that focus on various assessments, considerations, recommendations, and approaches. 

  • Executing Signals And Responses In A Continued Process Verification Program

    Part 1 of this series provided an overview of CPV and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

FDA FY2019 Drug Inspection Observations And Trends FDA FY2019 Drug Inspection Observations And Trends

A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP drug inspection data from CDER, which addresses drug inspections conducted in FY2019. The FDA published data from FY 2018 in September 2019 and we recently addressed that data; FY2019 data was published on Nov. 15, 2019. Here we examine data from FY2019, along with seven years’ worth of trends in drug GMP inspections.

Biocompatibility Considerations For Drug Delivery Devices — An Introduction To ISO 10993 Biocompatibility Considerations For Drug Delivery Devices — An Introduction To ISO 10993

Biocompatibility is an essential element for any pharmaceutical combination product. ISO 10993 is the standard for biocompatibility, and it is broken into various normative sub-standards from ISO10993-1 to -22 that focus on various assessments, considerations, recommendations, and approaches. 

Executing Signals And Responses In A Continued Process Verification Program Executing Signals And Responses In A Continued Process Verification Program

Part 1 of this series provided an overview of CPV and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part, we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.

More From Pharma Contributing Editors