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