Summary of presentation by Doug Kovacs, Supervisory Investigator, FDA- New Jersey District
At the recent Contract Pharma show, hosted in New Brunswick, NJ, Doug Kovacs spoke about the top 10 483 observations in 2014. His focus was on sterile manufacturing facilities and how this compared to 2009. In this summary only the items that FDA found for 2014 are presented and the issues that FDA sees going forward. The FDA issued 645 Observations in 2014. This number does not include observations that were prepared manually. The following are summaries of the top 10 items:
#1 – Quality Control procedures were not followed
#2 – Laboratory controls did not conform to appropriate standards
#3 – Failure to record items
#4 – Procedures to assure drug products have ID, strength, quality and purity either did not exist or were not sufficient.
#5 – SOP’s were not followed
#6 – Procedures designed to prevent microbiological contamination of drug product purporting to be sterile are not established, written or followed.
#7 – During the testing and release of drug product, OOS investigations not followed
#8 – Hold times – for cleanings, sterilization etc… – were not validated
#9 – Routine calibration, inspection, and qualifications of equipment was found insufficient
#10 – No written testing program designed to assess the stability characteristics of drug products – backlogs are not acceptable too
The FDA hired many new investigators in 2014 which should help in the need for overseas inspections. The number of inspections preformed in country versus out of county in 2014, was 935 and 782 respectively. The number of inspections internationally has almost doubled since 2009.
The FDA is also changing how they are organized, though this is not official. FDA is going to a specialty management, where managers will be in charge of certain areas across the nation versus having a diverse group of inspectors locally. This change is designed to make inspections more uniform across the districts, addressing concerns about inconsistencies in inspection rigor.