I am trying to understand what constitutes design under 9001.
We got 9001 certified with a design exclusion as we have been doing contract fermentations (no not beer! )...
But now we are considering developing our own product where we clone an organism, ferment to produce an enzyme, partially purify it and sell it as technical grade...
We may only (but not necessarily?) sell it only to one customer that we do contract fermentations for.
Unlike what we do for contract manufacturing we would own the whole production process for this enzyme ( but this would not be a novel product or use novel technology and others already sell it commercially)
An argument has been made that since the target enzyme is a known commercial product produced by others, we would be manufacturing to specs already in the market place and it is not a novel enzyme , we are not doing development but rather only working out manufacturability, and so could keep our design exclusion...
Is that likely the case? We are a small company and don't want to slow down such development work.
We will also be going for 13485 (we can do contract manufacturing of biologics that could go into diagnostic kits and vaccines) but we would only be a "component" manufacturer providing crude product that get purified etc by customers that use it in those products. I am assuming that if we did a product of our own it would only be under 9001 and not 13485... I assume we could do that?
Thanks for any feedback
-Karen
We got 9001 certified with a design exclusion as we have been doing contract fermentations (no not beer! )...
But now we are considering developing our own product where we clone an organism, ferment to produce an enzyme, partially purify it and sell it as technical grade...
We may only (but not necessarily?) sell it only to one customer that we do contract fermentations for.
Unlike what we do for contract manufacturing we would own the whole production process for this enzyme ( but this would not be a novel product or use novel technology and others already sell it commercially)
An argument has been made that since the target enzyme is a known commercial product produced by others, we would be manufacturing to specs already in the market place and it is not a novel enzyme , we are not doing development but rather only working out manufacturability, and so could keep our design exclusion...
Is that likely the case? We are a small company and don't want to slow down such development work.
We will also be going for 13485 (we can do contract manufacturing of biologics that could go into diagnostic kits and vaccines) but we would only be a "component" manufacturer providing crude product that get purified etc by customers that use it in those products. I am assuming that if we did a product of our own it would only be under 9001 and not 13485... I assume we could do that?
Thanks for any feedback
-Karen