Case Study 1: Managing Efficiency in a Quality Organization

By Joe Barbarite, Par Pharmaceutical and Rafi Maslaton, cResults

This case study discusses efficiency management throughout the quality operations including QC laboratories and QA operations. In addition, it outlines how Par Pharmaceutical has addressed operational excellence in its quality operations and how it improves its cost effectiveness and enhances its compliance value added contribution to manufacturing and packaging operations at its Spring Valley, New York site.

For a full article, please click on the following link: http://www.nxtbook.com/ygsreprints/ygs/phpr_1-24628441/

The results observed after 3 months of cME implementation at Par Pharmaceutical, a leading generic company, are as follows:

§         Errors in batch records were reduced in the month of August by 29.7%

§         Response time of Manufacturing to correct errors was reduced by 18.7%

§         Reviewer efficiency is up over 10%

§         With cME information, the number of reviews are expected to be reduced by 50%

§         Many traditional QA activities are being challenged via cME’s visibility of value-added / non value-added activities