FROM THE EDITOR

Quality Culture Tips From Pharma Pros

Leading minds from Merck, Perrigo, and the Harvard Business Review share their best practices for building a culture of quality in pharma, and all agree on one overarching principle – ensuring quality is every employee’s responsibility. 

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PHARMA MANUFACTURING INSIGHTS

  • The Ongoing Push For Human Abuse Liability Studies In The EU
    The Ongoing Push For Human Abuse Liability Studies In The EU

    Human Abuse Liability (HAL) studies use clinical procedures that were initially developed in the United States. European nations have had little experience in developing and applying these techniques, which is leading some to question whether more thorough testing could have forestalled some difficulties with addiction, diversion, and other societal harms. 

     

  • Can Diamond Make Drug Authentication “Flawless?”
    Can Diamond Make Drug Authentication “Flawless?”

    Pharmaceutical industry insiders estimate that more than $350 billion worth of counterfeit drugs are now sold around the world each year.  In addition to diverting revenue from manufacturers and distributors, falsified medicines are also putting patients at risk. They are often not manufactured to even minimum quality standards, which can reduce their efficacy.  In addition, in many cases they contain dangerous impurities that pose significant safety hazards.

  • Protecting Products To Save Lives: Securing The Pharma Supply Chain
    Protecting Products To Save Lives: Securing The Pharma Supply Chain

    Over the past decade the world market for pharmaceuticals has nearly doubled, reaching a total value of approximately $1 trillion. While the industry will continue to develop, its days of consistent high growth appear to be over – a casualty of multiple factors, including healthcare spending cost control efforts, the demise of the ‘blockbuster’ drug and the rise of generics.

  • Prioritizing The BioPharma Portfolio – Get The Right Assets On The Bus (and The Wrong Ones Off)
    Prioritizing The BioPharma Portfolio – Get The Right Assets On The Bus (and The Wrong Ones Off)

    Everyone is looking for the silver bullet: the product that will change the face of biopharmaceuticals and draw blockbuster revenues. If you have one of these, you can stop reading. But if you are like most companies, your portfolio is a mix of some winners, some underachievers, and a lot of “in-betweeners.” The process of getting the right assets on the bus (and funded) in a cash-strapped environment is as much an art as a science. As consultants to the industry for many years, we’ve seen myriad processes – both good and bad. 

  • Transfer Of Lab Automation And Handling Concepts From Chemical To Pharmaceutical Applications
    Transfer Of Lab Automation And Handling Concepts From Chemical To Pharmaceutical Applications

    Laboratory automation has significantly changed chemical and pharmaceutical research since the 1980s. Complex automation and handling solutions provided by Bosch have proven successful in chemical laboratories for a long time. Bosch Packaging Technology is now transferring its concept of lab automation and handling to the pharmaceutical market. Based on its packaging and pharmaceutical know-how, Bosch offers the pharmaceutical industry highly flexible, tailor-made solutions along the value chain.

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PHARMA CONTRIBUTING EDITORS

  • Love Me, Love Me Not — The Life Science Industry’s Paradox
    Love Me, Love Me Not — The Life Science Industry’s Paradox

    Cold-hearted logic dominates the quest for shareholder value, even as industry insiders complain that “nobody loves us.” What better example of the conundrum exists than the current commentary about Gilead and its wonder drugs for Hep C?

  • Does Adversity Build Character Or Reveal It?
    Does Adversity Build Character Or Reveal It?

    Denice Torres is the president of McNeil Consumer Healthcare, a Johnson & Johnson company, and winner of HBA’s 2015 WOTY award. Listening to her acceptance speech reminded me of legendary pro football coach Vince Lombardi’s philosophy — “Adversity doesn’t build character, it reveals it.” 

  • Quality Risk Management: Reduce Risk By Embracing It
    Quality Risk Management: Reduce Risk By Embracing It

    Despite the resources available to help companies develop a QRM program, such as the ICH Q9, there are several challenges that commonly prevent a successful implementation. Ghada Haddad, director in global sterile and validation at Merck, suggests several best practices that can help overcome these issues. 

  • Quality Culture Tips From Pharma Pros
    Quality Culture Tips From Pharma Pros

    Leading minds from Merck, Perrigo, and the Harvard Business Review share their best practices for building a culture of quality in pharma, and all agree on one overarching principle – ensuring quality is every employee’s responsibility. 

  • Pharma’s Orphan Drug Binge: Redefining Corporate Social Responsibility?
    Pharma’s Orphan Drug Binge: Redefining Corporate Social Responsibility?

    A few months ago, Senator Elizabeth Warren launched a proposal for a “swear jar” bill that would require law-breaking Big Pharma companies to contribute 1 percent of the profits from each of their blockbuster drugs to NIH research. While this proposal was highly contested by members of the industry, I questioned if there couldn’t be a benefit to this bill apart from punishing law breakers and bolstering drug R&D. Would seeing pharma push more of its profits into research boost the industry’s image?   

More From Pharma Contributing Editors

PHARMACEUTICAL ONLINE VIDEOS

  • How Are Your Operators Breaking Up Materials In Drums?
    How Are Your Operators Breaking Up Materials In Drums?

    Custom Powder Systems makes a product called a drum massager. It has two sets of C-shaped arms that come in and compress the drum. There's a turntable that turns the drum, compresses it again. It raises up, does additional compressions, and cracks up, breaks up the material.

  • A Plug-in Transfer Cart To Fit Production Needs
    A Plug-in Transfer Cart To Fit Production Needs

    If you have a facility with unclassified hallways and you need to transfer product or vials or anything from a classified area to a filling area, passing through an unclassified area, the transfer cart (Lyo Cart) will help you solve that problem.

  • Video: Cold Box + LTL Trucking = Cold Box Express
    Video: Cold Box + LTL Trucking = Cold Box Express

    This 90-Second Video Introduces Alternative to Traditional Reefer and Passive Shipping

  • QbD: An Effective Roller Compaction Process
    QbD: An Effective Roller Compaction Process

    A description of the Roller Compaction process and the various process parameters that affect the quality of the roller compacted ribbons. Feed rate, compaction pressure, and roll speed are all discussed.

  • Quality and Manufacturing Complete Control- Keeping Documents on Track
    Quality and Manufacturing Complete Control- Keeping Documents on Track

    Trying to keep track of up-to-date documents and templates can be like chasing down…well you know. But with EMC Documentum Quality and Manufacturing time-consuming reviews and approval efforts can be minimized with centralized control and a unified document repository- all while adhering to GMP compliance and mitigating risks and delays.

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FEATURED SUPPLIERS

  • rommelag USA, Inc.
    rommelag USA, Inc.

    Rommelag® is the principal world-wide developer and supplier for advanced aseptic Blow/Fill/Seal pharmaceutical packaging equipment. Rommelag invented aseptic Blow/Fill/Seal technology over 40 years ago, since then we have continued to meet and exceed our customers packaging requirements

  • Marken
    Marken

    Founded in 1980, Marken is focused on supporting Life Science companies assure the quality and integrity of clinical trial specimens and vital medications through the logistics chain. For nearly two decades, Marken has extended the reach of Pharmaceutical companies, research laboratories and clinical trial research organizations bridge the distance between patients and life science investigative resources.

  • Cold Box Express, LLC
    Cold Box Express, LLC

    Cold Box Express, LLC offers the only temperature controlled shipping container suitable for dry freight or LTL trucking transport. Able to actively protect temperature sensitive payloads from cold or heat, the battery operated Cold Box allows for 3 – 5 day shipment of high value single-pallet commodities along with dry freight or cargo.
    With the option to ship with LTL trucking companies, the Cold Box not only expands the transportation and storage options for typical and high value temperature sensitive cargo, but also provides uninterrupted temperature critical performance ensuring Cold Chain integrity.

  • Gerteis Maschinen + Processengineering AG
    Gerteis Maschinen + Processengineering AG

    GERTEIS is your perfect partner for dry granulation systems. We specialize in the design, development and production of premium roller compactors for the pharmaceutical, chemical and food industries.

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DEVOTED TO TECHNOLOGY: INTERPHEX 2015

State-of-the-Art Technologies, from Automation to 3D Printing to Barrier Isolation, INTERPHEX 2015 to Feature MORE of the Very Latest in Innovation, Technologies and Knowledge.

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 UPCOMING TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements

June 1, 2015
2pm-3:30pm EDT, Online Training

FDA GMP Inspections – Proven Preparation & Survival Techniques

June 2, 2015
1pm-2:30pm EDT, Online Training

Cost-Efficient/Cost-Effective Validation Protocols

June 3, 2015
1pm-2:30pm EDT, Online Training

Identifying and Closing the Training Gap in Clinical Research

June 9, 2015
1pm-2:30pm EST, Online Training
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 PHARMACEUTICAL EVENTS

Webinar on Critical Control Points

May 29, 2015
Mississauga, ON

Pediatric Clinical Trials: Special Considerations and Requirements

June 1, 2015
2pm-3:30pm EDT, Online Training

6th Digital Pharma West

June 1 - 3, 2015
Burlingame, CA

FDA GMP Inspections – Proven Preparation & Survival Techniques

June 2, 2015
1pm-2:30pm EDT, Online Training
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