Current regulatory inspection is come up with lots of recommendations. In this article will be discussing regarding the different regulatory requirements. This is the time to evaluate our existing procedure and mitigating the risk. Here will discuss about the recommendation which received different regulatory authority. Keep your eyes to our blog and check whether you are complying to below mentioned recommendations,
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Sr. No.
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Category
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Recommendations
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Background
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Risk mitigation/ Justification
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1
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Facility
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Seasonal variation need to be evaluate for storage areas /location like finished goods / packing material storage
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To evaluate the impact of seasonal variation on HVAC system
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During initial qualification min 3 seasons (with 4 month interval) need to be evaluated.
Based on that hot spot need to be identified.
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Last Update : 17-08-2017
We will update soon….
I really want to add something to your knowledge that there are many pharmaceutical companies that sometimes offers wrong alternatives for the medicines so try to create awareness about that companies too. Thanks