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

  • 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.

  • 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."

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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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    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.


     

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