Business Continuity Plan for manufacturing a IVD

invitro_spain

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#1
Hi all!

Anyone knows how to do a "Business continuity plan" for the manufacturing of a In Vitro Medical Device? Any help would be apreciated.

Thanks
 
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Richard Regalado

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#3
Hi all!

Anyone knows how to do a "Business continuity plan" for the manufacturing of a In Vitro Medical Device? Any help would be apreciated.

Thanks
Why establish a BCP for the manufacturing process only? If you can't deliver the products, how can you continue the business?

You need to understand the organization first, identify the business drivers for having a BCP before you can come up with an effective BCP.

Look at BS 25999 for inspiration.
 
P

pldey42

#4
Richard's suggestion reminds me that I once met someone who owned a factory that made syringes pre-loaded with a measured dose of some kind of medicine. It had a short shelf life, and he was its sole supplier, so if the factory was unable to supply for any reason, people could die.

When he arrived at our BS 25999 course his question was something like, "How do I do business continuity for my factory?" One significant constraint was that the manufacturing equipment was expensive and only built to special order. The lead time was longer than the shelf life of his product, so a BC plan that involved stock-piling enough product to sustain patients until the factory could be rebuilt would not work. Even if he could rebuild the factory, it would take so long the product's reputation for reliable supply would be trashed.

He owned some significant patents, I think, and could continue research, marketing and sales with fairly simple BC plans. He realized that his key product was, not the manufacture of pre-loaded medicinal syringes, but their reliable supply. By the end of our course he was seriously considering outsourcing manufacture to two contract manufacturers, separately owned and in geographically different locations, and closing his own factory.

Hope this helps,
Pat
 
K

kerlinfaxo

#5
The Best business continuity plan for manufacturing a IVD , the manufacturer should be capable to add value during the technical transfer of an IVD product regardless of its complexities. The demand for more applications naturally leads to a need for greater capacity in essay manufacturing. Bearing this in mind , IVD companies must remain as competitive as possible to stay ahead of the curve, which has influenced the products that they are developing and manufacturing. Whether the product is highly marketable or demand for it is unpredictable., companies must ensure that it can be manufactured on time, in the required numbers, with high quality, and cost effectively. For addressing these critical challenges , an IVD company may need to search for a contract manufacturer.



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