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The Information Source for the Pharmaceutical Manufacturing Industry

Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers.

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  • Recommendations For Managing Complexity In Pharmaceutical Operations

    There is an inherent tendency in pharmaceutical operations to make things much more complex than they need to be. “More” is considered to be better, what regulators want to see. However, more content in an SOP, additional signatures, and new forms and control loops do not necessarily equate with “better.”

  • Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?

    Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

  • Why You Need A World-Class Quality Culture — And How To Build One

    The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

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  • Safety Department At Cleanroom Manufacturer Ensures No One Gets Hurt

    AES takes the well-being and safety of all of our team members very seriously. In this video, AES director of EHS Tony  Mangabat highlights some of the measures our safety department takes to ensure no one gets hurt at AES.

  • Cleanroom Manufacturer Expands Capacity To Meet Industry Needs

    AES Clean Technology builds more cleanrooms than anyone else. The market is busy, and so are we... but are we too busy? The answer is a resounding "NO, AES is not too busy!" We plan our cleanroom design, panel manufacturing, and manpower loading and scale as needed. We currently have the capacity to more than double our panel manufacturing.

  • 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.

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There is an inherent tendency in pharmaceutical operations to make things much more complex than they need to be. “More” is considered to be better, what regulators want to see. However, more content in an SOP, additional signatures, and new forms and control loops do not necessarily equate with “better.”

Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

The forced degradation study is a vital analytical aspect of the drug development program for small molecules. Commonly known as stress testing, it is carried out to demonstrate as specificity to developed a stability-indicating analytical method, using high-performance liquid chromatography (HPLC). As per ICH Q1A, stability studies must be performed to propose the shelf life of new drug substances and/or drug products.

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CONTACT INFORMATION

Pharmaceutical Online

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Phone: 814-897-7700

TITLE SUMMARY DISPLAY

  • Recommendations For Managing Complexity In Pharmaceutical Operations

    There is an inherent tendency in pharmaceutical operations to make things much more complex than they need to be. “More” is considered to be better, what regulators want to see. However, more content in an SOP, additional signatures, and new forms and control loops do not necessarily equate with “better.”

  • Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?

    Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

  • Why You Need A World-Class Quality Culture — And How To Build One

    The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

GRID WITH IMAGE DISPLAY

There is an inherent tendency in pharmaceutical operations to make things much more complex than they need to be. “More” is considered to be better, what regulators want to see. However, more content in an SOP, additional signatures, and new forms and control loops do not necessarily equate with “better.”

Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.