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  • An Analysis Of FDA FY2016 Drug GMP Warning Letters
    An Analysis Of FDA FY2016 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

  • 4 Major Trends In Pharmaceutical Packaging
    4 Major Trends In Pharmaceutical Packaging

    There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.

  • Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare
    Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

    If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

More From Pharma Contributing Editors

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An Analysis Of FDA FY2016 Drug GMP Warning Letters An Analysis Of FDA FY2016 Drug GMP Warning Letters

This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

4 Major Trends In Pharmaceutical Packaging 4 Major Trends In Pharmaceutical Packaging

There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.

Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

CAPA Effectiveness Checks 101: How To Verify That Your Actions Plans Are Successful CAPA Effectiveness Checks 101: How To Verify That Your Actions Plans Are Successful

Verifying the effectiveness of a CAPA closes the loop between identifying a problem and completing the actions to solve a problem. This article explains how to choose an appropriate measurement for CAPA effectiveness checks, what methods to use, and when to perform them.

More From Pharma Contributing Editors

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TITLE SUMMARY DISPLAY

  • An Analysis Of FDA FY2016 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

  • 4 Major Trends In Pharmaceutical Packaging

    There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.

  • Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

    If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

An Analysis Of FDA FY2016 Drug GMP Warning Letters An Analysis Of FDA FY2016 Drug GMP Warning Letters

This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

4 Major Trends In Pharmaceutical Packaging 4 Major Trends In Pharmaceutical Packaging

There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.

Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

More From Pharma Contributing Editors