FAILURE INVESTIGATION

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Summary of f data d review � Trend data of quality parameters � Stability y data � Trend of Manufacturing parameters � Process timings and hold times � Equipment usage �� Cleaning history / line clearances � People deployed in operations � MMaterials i l used d � Environmental conditions
Conclusions of data review � Provide data analysis � Si Scientific ifi jjustification ifi i � Include both positive and negative conclusions � Collect more data if data collected earlier is not resulting definite conclusion or suggest review of some other h parameters not seen earlier. li
Page 1 and 2: FAILURE INVESTIGATION GGanadhish dh
Page 3 and 4: What is Failure & Failure Investiga
Page 5 and 6: Regulatory requirements � 21 CFR
Page 7 and 8: Regulatory requirements �� Eudr
Page 10 and 11: Causes of failure or variation �
Page 12 and 13: Identify probable causes Investigat
Page 14 and 15: Factors to be explored for 6 M’s
Page 16 and 17: Factors to be explored for 6 M’s
Page 18 and 19: Five Whys? � The 5 Whys is a ques
Page 20: CCritical iti l information i f ti
Page 23 and 24: CAPA [21CFR [ 820.100] ] Includes A
Page 25: Regulatory requirements � ICH Q10
Page 28 and 29: PProblem bl dfiiti definition � U
Page 32 and 33: Experimental Plan � Scientific ra
Page 34 and 35: CAPA � Identification of correcti
Page 36 and 37: C Case study t d
Page 38 and 39: Collection & evaluation of the data
Page 40 and 41: � CAPA Improvement & control meas
Page 42 and 43: PProblem bl definition dfiii � Mi
Page 44 and 45: DData analysis l i � Microbial gr
Page 46: Any Questions?

FAILURE INVESTIGATION

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