FROM THE EDITOR

Pharma’s Quest For Consistent Quality

The preliminary findings from the International Society of Pharmaceutical Engineering’s (ISPE’s) Quality Metrics Pilot Program were revealed at the association’s recent Quality Metrics Summit. How will this data help the pharma industry create a universally accepted set of manufacturing quality standards and what challenges did the pilot uncover?

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PHARMA MANUFACTURING INSIGHTS

  • 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.

  • Installation Of A Purified Water System For The Production Of Protein Plasma Manufacturing
    Installation Of A Purified Water System For The Production Of Protein Plasma Manufacturing

    The Central Fractionation Unit of the Belgian Red Cross (C.A.F.-D.C.F.) headquartered in Brussels supplies the domestic market with plasma proteins and acts as a contract manufacturer.

  • Bosch Packaging Services Modifies Thermoforming Line For Siemens And Co
    Bosch Packaging Services Modifies Thermoforming Line For Siemens And Co

    Even the most durable packaging machine will need spare parts sooner or later. But what is to be done if the necessary electronic components are no longer available?

  • 10 Basics To Achieving Labwasher Cleaning Validation
    10 Basics To Achieving Labwasher Cleaning Validation

    For pharmaceutical processes, validation is key as it assures consistency, quality, and keeps operations compliant with the FDA’s Current Good Manufacturing Practice regulations, or cGMP. While the FDA provides proper cleaning validation guidance, challenges occur as interpretation of those procedures may vary between facilities.

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PHARMA CONTRIBUTING EDITORS

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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
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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.

INDUSTRY PARTNERS

 

 

PHARMACEUTICAL ONLINE SUPPLEMENTS

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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

Building An Effective GMP Training System: A Risk-Based Approach

May 27, 2015
1pm-2:30pm EDT, Online Training

Introduction to Biostatistics: Collecting and Summarizing Data

May 28, 2015
1pm-3pm EDT, Online Training

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
More Upcoming Courses

 PHARMACEUTICAL EVENTS

Building An Effective GMP Training System: A Risk-Based Approach

May 27, 2015
1pm-2:30pm EDT, Online Training

Introduction to Biostatistics: Collecting and Summarizing Data

May 28, 2015
1pm-3pm EDT, Online Training

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
More Events....