Compliance to regulatory requirements in Pharmaceutical industries

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,   

Sr. No.
Category
Recommendations
Background
Risk mitigation/ Justification
1
Facility
Seasonal variation need to be evaluate for storage areas /location like finished goods / packing material storage
To evaluate the impact of seasonal variation on HVAC system
During initial qualification min 3 seasons (with 4 month interval) need to be evaluated.
Based on that hot spot need to be identified.


Note: Post your comments if you have any query. 
Last Update : 17-08-2017

We will update soon….

About PRES

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This entry was posted in Pharmaceutical and Biotechnological. Bookmark the permalink.

1 Response to Compliance to regulatory requirements in Pharmaceutical industries

  1. 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

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