 Richard Bahr MGS President and CEO Visit Website |
Richard has 20 years of experience in management with MGS. He has overseen and directed the building of a growing organization and building of the MGS reputation in the marketplace. Richard has provided key leadership in initiating the development of at least one new product each year since becoming President in 1996. He has sat on multiple industry panels and is frequently sought after for commentary on pharmaceutical packaging automation, most recently regarding compliance packaging formats. He currently serves on the PMMI board of directors.
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Automation Q&A
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Asked September 14th, 2009
Follow GAMP 5, which is a Risk-Based Approach to Quality.
a. First you need to identify the functions that have an impact on Patient Safety, Product Quality, and Data Integrity. Your company policy should dictate the acceptable level of risk for each. The aforementioned items will need to be mitigated until an acceptable risk level is reached. Validation will subject these to a higher level of testing. One example of this is a bar code identification system.
b. Items not listed above can be subjected to Good Practice and can undergo Basic Testing at Commissioning. One example of this is a low-level sensor for a carton magazine on a cartoner.
c. A great source for reference material is at http://www.ispe.org/cs/jett/gamp_americas_jett_sample_docs. Download the document JETT Risk-Based Approach to Automated Equipment R01
