Process Validation Again Among the Top Five in the Warning Letters Report for Medical Devices

GMP News No. 903: Process Validation Again Among the Top Five in the Warning Letters Report for Medical Devices

GMP News
14 March 2007
 

Process Validation Again Among the Top Five
in the Warning Letters Report for Medical Devices

 
Not long ago, the Warning Letters Report for medicinal products was published (see our GMP News of 10 January 2007). In the following we describe the development of the top five of the warning letters statistics between 2002 and 2006 with regard to medical devices. In doing so, we refer to FDA's fiscal years, which always begin on 1 October of the previous year and end on 30 September.

After the big number of warning letters published in 2004 (104) and 2005 (106), the total number decreased to "just" 79 warning letters in 2006. However, the number is still higher than in 2002 and 2003 (61 each).

There is some movement in ranks 2 to 5, although the "usual suspects" reappear time and again among the top five. Like in the previous years, CAPA was the top offender in 2006. Meanwhile, process validation has reached rank 5 again. While it ranked 2nd in 2002, it slid down to rank 8 in 2003, occupied rank 9 in 2004 and went slowly up to rank 7 in 2005.

The following table gives an overview of the top five deficiencies (WLs = warning letters):
 

Year Number WLs Rank 1 Rank 2 Rank 3 Rank 4 Rank 5
2002 61 .100 .75 .198 .30 .70
2003 61 .100 .30 .198 .20 .80
2004 104 .100 .20 .22 .30 .80
2005 106 .100 .198 .80 .20 .22
2006 79 .100 .30 .198 .80 .75

 
The table lists only the endings of the CFR numbers.

  • 21 CFR 820.20: Management responsibility
  • 21 CFR 820.22: Quality audit
  • 21 CFR 820.30: Design controls
  • 21 CFR 820.70: Production and Process control
  • 21 CFR 820.75: Process validation
  • 21 CFR 820.80: Receiving, in-process, and finished device acceptance
  • 21 CFR 820.100: Corrective and preventive action
  • 21 CFR 820.198: Complaint files

 

To give you an overview of the cGMP requirements on the whole range of validation /qualification, the ECA has designed the practice-oriented 3-day GMP Education Course The Validation Manager. The course takes place in Berlin, Germany, from 10-12 October 2007.

 
Author:
Sven Pommeranz
On behalf of the European Compliance Academy (ECA)
  

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