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

  • 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.

  • Load Cells For A Portable Structure
    Load Cells For A Portable Structure

    We know that a weighing system must be rigid to get good results. We should also know that a three point system is inherently more stable than a four point system as three points define a plane. We know that we can convert a four wheel portable vessel to a three point system by using a double frame design “sandwich concept."

  • Transitioning To An Enterprise-CMS (Environmental Monitoring System) In A Regulated Environment
    Transitioning To An Enterprise-CMS (Environmental Monitoring System) In A Regulated Environment

    Does this sound familiar to you? Every day your facility staff manually checks the temperature of each refrigerator, freezer and temperature controlled chamber to maintain proper storage conditions in your GxP facility. It takes a lot of time each day, especially as you have in excess of 50 measuring points.

  • Losing Everything: Are Chart Recorders Enough?
    Losing Everything: Are Chart Recorders Enough?

    Perhaps, unfortunately, this scenario is all too familiar: You arrive at work on Monday morning and hear an alarm sounding from your refrigerator. You walk over to your fridge to check the chart recorder and see abnormal spikes on the paper graph, but a detailed analysis by quality control personnel is required to take any action whatsoever. You find out that the chart doesn’t show enough data for a quality-based decision, so the product inside has to be discarded. Panic sets in. The monetary value of the supplies pales in comparison to the fact that patients today are relying on the medicine inside.

  • Central Monitoring Systems 101: Better Control Of Critical Assets
    Central Monitoring Systems 101: Better Control Of Critical Assets

    Professionals working in any regulated environment know all too well that the technologies and devices used to perform everyday tasks vary by department, lab, floor, building and even by office. This is especially true when it comes to environmental and temperature monitoring. Some departments may use chart recorders, others manually record temperatures twice per day, while the laboratory down the hall uses thermometers, and then another area has stand-alone data loggers. While all these methods may meet very basic regulatory guidelines, as a facility, is your data easily accessible and are the appropriate alarm methods in place? If the answer is no, consider a central monitoring system to streamline data storage.

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PHARMA CONTRIBUTING EDITORS

  • 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.

  • FDA News Roundup: Otsuka, AstraZeneca, Ipsen, And More
    FDA News Roundup: Otsuka, AstraZeneca, Ipsen, And More

    What FDA decisions have you missed recently?

  • Human Error: What Pharma Should Know And Do About It — Part One
    Human Error: What Pharma Should Know And Do About It — Part One

    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 one of this four-part series, Gallant discusses where the industry currently stands in identifying the root cause of a problem, as well as the extent to which industry turns to human errors as an explanation.

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