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