Process Validation [View Printable]
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lizzy
Group: Member
Posts: 1
Joined: Jul 14, 2005
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Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis? |
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 Posted Jul 14, 2005, 5:19 AM |
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Bettye
Group: Member
Posts: 137
Joined: Dec 29, 2004
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| lizzy said: | | Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis? |
My thoughts are that it should be repeated, but I'm not sure how often, sort of like calibration of equipment... |
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| Posted Jul 14, 2005, 21:57 PM |
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l-gold
Group: Member
Posts: 2
Joined: Aug 03, 2005
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| lizzy said: | | Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis? |
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| Posted Aug 03, 2005, 9:34 AM |
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l-gold
Group: Member
Posts: 2
Joined: Aug 03, 2005
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| lizzy said: | | Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis? |
To my knowledge, as long as the process parameters and equipment does not change at all, and the final product is properly quality tested with no problems, revalidation is neccessary every three years. |
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| Posted Aug 03, 2005, 9:39 AM |
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jachmoody
Group: Member
Posts: 100
Joined: Feb 28, 2005
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I believe you'll find guidance on FDA'S web site--most of the time 3 trials are expected for establishing repeatability and so statistical analysis can be done.
| lizzy said: | | Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis? |
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jim achmoody
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| Posted Aug 03, 2005, 11:54 AM |
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Deepu
Group: Member
Posts: 2
Joined: Nov 07, 2006
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| lizzy said: | | Can anyone tell me how often a validation of aseptic processes should be conducted? Is once enough or should it be repeated on regular basis? |
I hope you mean media fill by aseptic process validation. In that case you have to have three successful consecutive media fills using SCDM (for aerobes)for lowest as well as highest fill. After that you have to repeat every six months.This study you can alternate with highest or lowest fills. In case if you are using nitrogen flushing you have to use Fluid thioglycollate medium as the media. For acceptance level you can refer PIC/S guideline for aseptic process validation |
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| Posted Nov 08, 2006, 4:07 AM |
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