APR 04, 2018 8:00 AM PDT

Reducing Human Errors in Pharmaceutical Manufacturing QC

Speaker
  • Senior Marketing Manager, Beckman Coulter
    Biography
      Tony held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in cleanrooms and was the UK subject matter expert to the ISO Working Group who issued the 2015 revised versions of the ISO 14644-1 & -2 documents for cleanroom classification at the heart of the aseptic manufacturing chapters of both the European GMP and the USA cGMP documents. Tony was joint editor on the ISPE Guide to Ozone Sanitization of Pharmaceutical Water Systems and was also chief editor of the PHSS Best Practice Guide for Cleanroom Monitoring. Tony is employed by Beckman Coulter Life Sciences as a Senior Manager.

    Abstract

    DATE: April 4, 2018
    TIME:  8:00 AM PDT, 11:00 AM EDT

    A recent report by CPhI highlights the pharmaceutical industry drive to improve productivity by improving right first time quality and reducing overhead costs1. Another report indicates that 79% of FDA 483 warning letters issued in 2016 cited data integrity issues2. Many quality control test procedures are still very manual and prone to human error, leading to errors and omissions in data records. So, we have an industry spending a large percentage of its operating costs trying to ensure product quality and in many cases failing while what is really needed is to automate the quality control processes to make them more robust and repeatable, delivering better right first time quality whilst at the same time improving data integrity and reducing operating costs.

    References:

    1. Pharma Manufacturing, CPhI Pharma Insights, UBM, 2016, www.cphi.com
    2. An Analysis of FDA Warning Letters, Barbara Unger, Unger Consulting Inc., Pharmaceutical Online Guest Column, July 14, 2017

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