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We're primarily (99+%) a medical device company, with thousands of products including fluid handling products that are manufactured or contract-manufactured for major international OEMs. We're being asked by an Asian (non-Chinese) firm, via their US representative, to manufacture for them a large annual volume of a fluid handling product for which we already have the manufacturing technology. Our product sold to them, however, will be in effect the distribution packaging for a fluid pharma product, which they will fill into our clean but nonsterile product, then heat-sterilize.
We want to make this product at our China plant. This will be our first pharma-regulated product worldwide.
Our understanding is that China has unique requirements in the Chinese Pharmacopeia (for which I'm not sure of the proper English abbreviation, but wer'e calling it SP) for the plastic film used to make this product, compared to the rest of the world. The customer presently is buying this product from a European maker that is using US-made film that meets USP, but not SP. We understand that the customer-country's regulatory authority wants materials used for this product-class to meet USP.
My understanding so far is that SFDA (Chinese FDA) requires that this product class if made in China, irrespective of intended marketing destination including export, must be made with material that meets SP. We're being told by leading world makers of plastic film specifically designed for this product class that they offer film that meets USP and is acceptable everywhere but China, and other film that meets SP and is acceptable in China, but does not meet USP...and thus would not be acceptable in the customer-country, at least not without our prospective customer jumping through additional regulatory hoops.
Sorry that this is expressed somewhat vaguely, but I'm constrained as to what I can disclose.
Anyone have any relevant experience with meeting both SP and USP for pharma fluid-handling products using the same material that will be heat sterilized?
We want to make this product at our China plant. This will be our first pharma-regulated product worldwide.
Our understanding is that China has unique requirements in the Chinese Pharmacopeia (for which I'm not sure of the proper English abbreviation, but wer'e calling it SP) for the plastic film used to make this product, compared to the rest of the world. The customer presently is buying this product from a European maker that is using US-made film that meets USP, but not SP. We understand that the customer-country's regulatory authority wants materials used for this product-class to meet USP.
My understanding so far is that SFDA (Chinese FDA) requires that this product class if made in China, irrespective of intended marketing destination including export, must be made with material that meets SP. We're being told by leading world makers of plastic film specifically designed for this product class that they offer film that meets USP and is acceptable everywhere but China, and other film that meets SP and is acceptable in China, but does not meet USP...and thus would not be acceptable in the customer-country, at least not without our prospective customer jumping through additional regulatory hoops.
Sorry that this is expressed somewhat vaguely, but I'm constrained as to what I can disclose.
Anyone have any relevant experience with meeting both SP and USP for pharma fluid-handling products using the same material that will be heat sterilized?