FROM THE EDITOR

FDA Paves Way For Intelligent Pills

The FDA’s approval of various edible sensor and tag technologies now makes it possible to tie digital data to traditional medicines. What does this development mean for pharmaceutical manufacturers?

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PHARMA MANUFACTURING INSIGHTS

  • 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.

  • 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

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INDUSTRY NEWS

  • 3SBio Acquires Zhejiang Wansheng Pharmaceutical

    3SBio Inc., (HKEX:1530) ("3SBio" or 'the Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it has acquired the entire equity interest in Zhejiang Wansheng Pharmaceutical Co., Ltd ("Zhejiang Wansheng") a limited liability company incorporated in the PRC for an aggregate consideration of RMB 528 million.

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FEATURED SUPPLIERS

  • Envirotainer
    Envirotainer

    We are a global market leading provider of an air cargo cold chain transportation concept to pharmaceutical companies and their logistics partners. We are unique and the benchmark for global air cargo cold chain management and logistics solutions.

  • 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.

  • 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.

  • 3M Purification, Inc.
    3M Purification, Inc.

    3M Purification (formerly CUNO) core filtration technologies address the most demanding applications in pharmaceutical processing for small molecule and active pharmaceutical ingredient (API) applications.

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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

Improving Biological Facility Design: Critical Tips for Compliance

July 28, 2015
1pm-2:30pm EDT, Online Training

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
1pm-2:30pm EDT, Online Training
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