FROM THE EDITOR

Bringing Legacy Pharma Manufacturing Facilities Into The Modern Age

Keeping your pharmaceutical manufacturing facilities up-to-speed with cGMP (current Good Manufacturing Practices) can be challenging, particularly when dealing with legacy facilities. This article provides some best practices on how to modernize legacy sites.

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PHARMA MANUFACTURING INSIGHTS

  • Excipients: The Unsung Heroes Of Pharmaceuticals
    Excipients: The Unsung Heroes Of Pharmaceuticals

    <p>Excipients are often described as inactive ingredients that assist in the delivery and processing of the active pharmaceutical ingredients. Although this is true, excipients have a much larger influence on final product performance than the term &ldquo;inactive ingredient&rdquo; suggests. In fact, choosing the right excipients is a key determinant of the quality and functionality of a pharmaceutical product.</p>

     

  • FDA & ICH: Regulations And Standards For Temperature-Controlled Supply Chains
    FDA & ICH: Regulations And Standards For Temperature-Controlled Supply Chains

    In this application note we look at the FDA regulations and ICH guidelines that address supply chain management for temperature-controlled pharmaceutical and biotechnical products.

  • Managing QbD From A CMO Perspective
    Managing QbD From A CMO Perspective

    The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.

  • Moving To A Modern Cold Chain Data Monitoring System
    Moving To A Modern Cold Chain Data Monitoring System

    In the world of pharmaceutical supply chains, where cost reduction is king and a growing number of products are temperature controlled – collecting, communicating and analyzing temperature and logistics data is critical to success.

  • Can Stability Data Save The Life Of Your Products, Preventing A Loss Of Millions?
    Can Stability Data Save The Life Of Your Products, Preventing A Loss Of Millions?

    At the end of a complex pharmaceutical supply chain, a product has seen many forms, labs, cities, containers, boxes, docks, trucks, storage facilities, data loggers and finally one patient. If the product is temperature controlled, how do you know it’s been kept in correct temperature and quality conditions from source of APIs, to manufacture, through multiple legs of distribution to patient? Many companies today haven’t asked themselves this question yet. But the regulators are.

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PHARMA CONTRIBUTING EDITORS

  • TPP Negotiations Stall, Hold Back Biosimilars Market
    TPP Negotiations Stall, Hold Back Biosimilars Market

    As if the biosimilar naming debate between brand-name pharmaceutical companies and generic drugmakers wasn’t enough, these two sides continue to challenge each other — this time, over biologics data exclusivity in the ongoing Trans-Pacific Partnership (TPP) negotiations.

  • Breaking News: Select Your CMO With Three (Well-Known) Attributes
    Breaking News: Select Your CMO With Three (Well-Known) Attributes

    Here’s your news bulletin: Another experienced source goes on record sharing three basics to selecting the best CMO: credibility, work ethic, and relationships. “I gained experience and understanding of outsourcing from running our own CRO,” says Chris K. Achar, CEO of Genzum Life Sciences.

  • New Teva, AstraZeneca Deals To Bolster Emerging Biosimilars Market
    New Teva, AstraZeneca Deals To Bolster Emerging Biosimilars Market

    After this week, it looks like there will be a few big players advancing in the biosimilar market. For those concerned about what a Teva-Mylan acquisition deal would do to the generics industry, recent action on behalf of Teva finally put those fears to bed.

  • Human Error: What Pharma Should Know And Do About It, Part Three
    Human Error: What Pharma Should Know And Do About It, Part Three

    When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science Training Institute’s expert Joanna Gallant describes, retraining employees is only going to go so far and, more often than not, will not even be the appropriate CAPA for the issue. In part three of this four-part series, Gallant discusses the underlying role management can play in contributing to human error and why the industry is less prone to identify management as a root cause of a problem.

  • The Biosimilar Naming Debate: Is Pharma Just Afraid Of Competition?
    The Biosimilar Naming Debate: Is Pharma Just Afraid Of Competition?

    The Boston Globe recently published an article revisiting the industry’s ongoing struggle to determine a labeling system for biosimilars— a challenge that reflects the industry’s insecurity over what seems to be an increasingly destabilizing generics environment.

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PHARMACEUTICAL ONLINE VIDEOS

  • Video: ActiFlow™: A NEW Material Flow Aid The ActiFlow Smart Bulk Solids Activator reliably prevents bridge-building and ratholing of cohesive bulk materials in stainless steel hoppers, in loss-in-weight feeding applications, eliminating the need for mechanical vertical agitation.
  • Video: ExpediteTC, Cold Chain Solutions For Pharmaceuticals American Airlines Cargo's ExpediteTC cold chain service, was created for the pharmaceutical industry as a packaged product that AA Cargo could stand behind, in order to give shippers more security and commitment to temperature-controlled solutions.
  • Thermo Scientific - At INTERPHEX New York 2010
    Thermo Scientific - At INTERPHEX New York 2010 Thermo Scientific – At INTERPHEX New York 2010, Jill Staggert and Brandon Pence from Thermo Scientific discuss the company’s online configurator and customization tools that allow users to design the solution needed for their critical application.
  • Exclusive RF Assisted Solutions Create Proactive Product Protection
    Exclusive RF Assisted Solutions Create Proactive Product Protection

    LoJack SCI's event-based comprehensive solutions integrated with the recovery-based beaconing technology create unique proactive protection for your products. This directionally based RF component adds the only technology solution that will generate search warrants due to the accuracy level of RF.

  • Pall Life Sciences - At INTERPHEX New York 2010
    Pall Life Sciences - At INTERPHEX New York 2010 Pall Life Sciences – At INTERPHEX New York 2010, Ian Sellick from Pall Life Sciences introduces the new Cadence filtration system.
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FEATURED SUPPLIERS

  • Micromeritics Instrument Corporation
    Micromeritics Instrument Corporation

    Micromeritics manufactures a broad line of automated analytical laboratory instruments that measure the physical characteristics of powders and solids for fundamental research, product development, quality assurance and control, production, and process control applications.

  • CSafe Global
    CSafe Global

    CSafe Global is the only global provider of a full line of cold chain solutions and is the world’s largest producer of actively controlled mobile refrigeration units for life sciences, healthcare, military and international disaster relief agencies.


     

  • Advanced Test Concepts (ATC Inc.)
    Advanced Test Concepts (ATC Inc.)

    Advanced Test Concepts, Inc. (ATC, Inc.) has offered our customers high quality, innovative and affordable Test & Measurement products for more than 20 years.

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    Thank you for your interest in Isolation Systems Inc., our products and capabilities. We offer full service design, engineering, and manufacture of a complete line of both standard and custom built airborne contamination control, containment, and extraction systems. Our systems assure the highest level of protection and safety for both personnel and product.

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 UPCOMING TRAINING COURSES

Project Management: Best Practices for Validation & Regulatory Projects

August 5, 2015
1pm-2:30pm EDT, Online Training

Electronic Informed Consent: New Guidance-Implications and Implementation

August 10, 2015
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Medical Device Complaint Handling and MDR Reporting

August 11, 2015
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Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle

August 12, 2015
1pm-2:30pm EDT, Online Training
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