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Document for Regulatory Department

document SOP WI

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Posted 27 November 2019 - 04:26 PM

Hi, my company has "Regulatory department/division" as a guide for regulatory activity (such how to comply to destination country or register a new product to government). The problem is, there is no SOP , Work Instructions yet in Regulatory Department/Division.


Can you assist me or give a list what  SOP and WI should we have? Can you give me example


Thanks  :helpplease: 


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Posted 27 November 2019 - 06:40 PM

I suspect this will depend very much on how your own company is set up - the division between regulatory, QA, "technical" etc varies quite widely between businesses.

How do you achieve what you're aiming in this area?
e.g. you presumably have procedures (even if not yet documented) to verify that raw materials, production processes, packaging materials, labelling, other documents provided (e.g. statements on regulatory compliance, form of ingredient declaration, legal name etc) all meet the requirements in the target market(s)?

This could be split by region to make more specific WIs - for example, for the US market you need to check a/b/c, for EU you check x/y/z etc.
Really I'm not sure there is much of a shortcut to following through your current process and writing that up as a starting point, and then reviewing it to fill in any gaps.


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Posted 27 November 2019 - 08:28 PM

Your Regulatory Department should be able to come up with some sort of draft of an SOP and WI if they are already doing the work.  My experience in regulatory included consulting with regulatory bodies, experts/consultants, reading relevant articles, subscribing to electronic notifications, etc - to guide me to proper regulatory classifications.  I would use standard statements for whatever declaration I was making.  Their first step in the process would be to get  supplier documentation related to the regulatory issue.  The supplier documentation is also a good place to start to get verbiage to use in your standard statements.  


Not sure if this helps with your question, but sometimes it just takes a little bit of information like this to get the writing started.


Good Luck!

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