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Cost of floor plan for GMP Certified production facility
Any suggestions on the cost of having a floor plan drawn up for a GMP-certified production facility?
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16 Replies
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Negative, Mike. I always winged it, having some remorse later in a few areas that I didn’t consult an industrial engineering firm or millwright on.
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Whoa, in what country are you located?
In our case, the floor plan has to be detailed and approved by the cosmetics regulating authority. Each room function must be identified, along with direction arrows (colour-coded) showing the flow of packaging material, finished product, personnel, and raw/bulk material.
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He’s in the USA
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Thanks Perry….
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When we moved from our old manufacturing site to a new site; our QA manager at the time drew up new site plans and asked our auditor to review them. The auditor came up with a few things he would like to see and the QA manager updated the plans to include comments from the auditor.
This was certainly cheaper than paying someone to do the plans for us.
BTW - Operations manager took those plans and ignored them and built something incompatible with future plans. We moved into the new site and he promptly resigned!
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To me, sounds a bit chaotic. Where is senior management in this scenario? Who gave the Operations Manager the authority to ignore the plans and build something incompatible with future plans?
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Think this shows priority - and not for quality.
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Absolutely.
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I guess that is corporate life.
One company buys out another, then employs ultracrepidarian managers who not only have no experience of the industry we are in but know enough to tow the company line with their pretty powerpoints and incomprehensible jargon where we have ‘medium term event horizons’ and the need to ‘litigate’ with other team members.
Meanwhile, in this company there are two people who actually do have industry experience propping up an organisation with deep pockets and zero competency.
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Yup - I remember those days - and everyone in the room nodding in unison to meaningless jargon.
If you’re in US - wave MoCRA at them, might be a like crucifix to a vampire.
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We are not US based - but our company has decided that the USA is to be our next ‘home base’ and so far everyone is oblivious to MoCRA. I’ve discussed it, sent emails out defining what needs to be done and by when.
Nope - I’m just putting in road-blocks. Oh well, they will find out soon enough and I have an email trail to back me up.
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That everyone is oblivious to MoCRA comes as no surprise. And for me, raises questions on the quality and safety of cosmetics in the USA.
I founded and managed a manufacturing company for 20 years based on European standards that were higher than MoCRA. It made sense and had advantages. The biggest was that it opened export markets. We were exporting globally, including to Europe and Japan.
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I actually had this discussion with my boss this morning. He was ‘unaware’ of this and wondered what we have done to mitigate the situation.
Thankfully I have emails dating back almost a year appraising him of the situation.
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<OK, I see you have your arse covered “Thankfully I have emails dating back almost a year appraising him of the situation.”
As I have experienced with GMP / QC audits undertaken by cosmetics authorities, there is not much room for interpretation, the GMP guidelines are straightforward, and those who are not up to the mark pay the price.
And I spent a LOT OF TIME training my staff. It pays off!!!!
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China has recently published new standards for cosmetics and since our business exports toothpaste to China, this affects us. The new regulations were published late September.
My boss is complaining that we should have let him know ‘months ago’ and not just now. The new regulations are to be implemented on 1st December this year. Our supposed head of innovation has no idea of innovation or regulation.
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Boss is frustrated. Unless he funded and named someone to follow Chinese reg’s - it’s on him.
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