Comments on: Is Origin Information for APIs Good for the Pharmaceutical Industry? http://blog.pharmtech.com/2008/04/11/is-origin-information-for-apis-good-for-the-pharmaceutical-industry/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 By: CMC guy http://blog.pharmtech.com/2008/04/11/is-origin-information-for-apis-good-for-the-pharmaceutical-industry/comment-page-1/#comment-206 CMC guy Fri, 11 Apr 2008 20:27:31 +0000 http://blog.pharmtech.com/?p=70#comment-206 This appears to be another simplistic approach to a complex problem and I see minimal value in listing Country of Origin since this can add no real substance to knowledge of actual manufacturing site quality. Ultimately it is responsibility of Sponsor Company to assure supply chain when they make those choices so must work with and build trust to get the quality desired and there have been way too many high profile failures. Major Pharma does source from China and India but think is with concerns and (hopefully) appropriate control systems. There is a bit of an uneven playing field (although shrinking fast) however is there tolerance for passing along premium prices when can get adequate quality at a dramatically lower cost. The big push against high prices flows back on limited resources at companies and FDA. There is need for improvements and focus should be on root causes not less relevant label displays. In terms of Baxter Heparin my reading suggest NMR was not a routine test on material (since is very uncommon to use NMR in QC environment) so looks bad only after the fact. The crime appears sophisticated in using a close analog (which had to be prepared synthetically?) that would not be detected by normal means so would slip through to increase bulk weight. Sabotage is hard to account for in any normal situation. This appears to be another simplistic approach to a complex problem and I see minimal value in listing Country of Origin since this can add no real substance to knowledge of actual manufacturing site quality. Ultimately it is responsibility of Sponsor Company to assure supply chain when they make those choices so must work with and build trust to get the quality desired and there have been way too many high profile failures. Major Pharma does source from China and India but think is with concerns and (hopefully) appropriate control systems.

There is a bit of an uneven playing field (although shrinking fast) however is there tolerance for passing along premium prices when can get adequate quality at a dramatically lower cost. The big push against high prices flows back on limited resources at companies and FDA. There is need for improvements and focus should be on root causes not less relevant label displays.

In terms of Baxter Heparin my reading suggest NMR was not a routine test on material (since is very uncommon to use NMR in QC environment) so looks bad only after the fact. The crime appears sophisticated in using a close analog (which had to be prepared synthetically?) that would not be detected by normal means so would slip through to increase bulk weight. Sabotage is hard to account for in any normal situation.

]]> By: Girish Malhotra http://blog.pharmtech.com/2008/04/11/is-origin-information-for-apis-good-for-the-pharmaceutical-industry/comment-page-1/#comment-205 Girish Malhotra Fri, 11 Apr 2008 18:18:30 +0000 http://blog.pharmtech.com/?p=70#comment-205 We can have two or more opinions on any subject. It is comes down to "how I can make money." SOCMA and EFCG have complained about Indian and Chinese companies but their members have NOW started to own facilities in the countries where they have complained that FDA has not done inspections. Interestingly Major Pharmaceuticals have no problem and/or concern in getting products from China and India. Since they are responsible Corporate Citizens, everyone would expect they are behaving responsibly. However, in the case of Heparin, it did not happen. Greed took over and adulteration happened. I looked at the NMR posted by FDA and there are differences between good and bad. Someone at Baxter dropped the ball. We expect FDA to cure all the manufacturing ills. My question is where is Corporate responsibility, what happened. Anything goes wrong, FDA get the blame. They are short of money and people. May be they should do the same thing FAA has done with American Airlines. We have inefficient processes run by 100 year old processes that are being monitored for quality (quality by analysis), we are lucky we have not had many more casualties. I am sure having the RIGHT process to deliver Quality by Design, much of the complaining would disappear. We can have two or more opinions on any subject. It is comes down to “how I can make money.” SOCMA and EFCG have complained about Indian and Chinese companies but their members have NOW started to own facilities in the countries where they have complained that FDA has not done inspections.

Interestingly Major Pharmaceuticals have no problem and/or concern in getting products from China and India. Since they are responsible Corporate Citizens, everyone would expect they are behaving responsibly. However, in the case of Heparin, it did not happen. Greed took over and adulteration happened. I looked at the NMR posted by FDA and there are differences between good and bad. Someone at Baxter dropped the ball. We expect FDA to cure all the manufacturing ills. My question is where is Corporate responsibility, what happened.

Anything goes wrong, FDA get the blame. They are short of money and people. May be they should do the same thing FAA has done with American Airlines. We have inefficient processes run by 100 year old processes that are being monitored for quality (quality by analysis), we are lucky we have not had many more casualties. I am sure having the RIGHT process to deliver Quality by Design, much of the complaining would disappear.

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