Comments on: Is Industry Ready to Share Supplier Audits? Rx-360 Takes a Shot. http://blog.pharmtech.com/2009/06/10/is-industry-ready-to-share-supplier-audits-rx-360-takes-a-shot/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 By: Sivakumar http://blog.pharmtech.com/2009/06/10/is-industry-ready-to-share-supplier-audits-rx-360-takes-a-shot/comment-page-1/#comment-23678 Sivakumar Fri, 20 Nov 2009 05:36:41 +0000 http://blog.pharmtech.com/?p=1403#comment-23678 The proposal of Shared audits is a good intiatives in the Pharmaceutical world. It reduces a lot of hassles in terms of getting supplier approval, delivery of goods from the approved source and regualators questions on unaudited supplies. However, the following points to be considered to maintain integrity of the reports and information gained, 1. Who is going to conduct audits and their qualfication, experience and reliability? 2. Who makes final decision and evaluation of audit reports written by the auditors before makes it public? 3. Is there any letter of authorisation from the audited company to share the reports to someone? 4. Is there any limitation in circulation of the reports? 5. Validity or retention of the reports with requestors or archivers? 6. Legal implication of the shared reports. The proposal of Shared audits is a good intiatives in the Pharmaceutical world. It reduces a lot of hassles in terms of getting supplier approval, delivery of goods from the approved source and regualators questions on unaudited supplies.

However, the following points to be considered to maintain integrity of the reports and information gained,

1. Who is going to conduct audits and their qualfication, experience and reliability?

2. Who makes final decision and evaluation of audit reports written by the auditors before makes it public?

3. Is there any letter of authorisation from the audited company to share the reports to someone?

4. Is there any limitation in circulation of the reports?

5. Validity or retention of the reports with requestors or archivers?

6. Legal implication of the shared reports.

]]> By: CMCguy http://blog.pharmtech.com/2009/06/10/is-industry-ready-to-share-supplier-audits-rx-360-takes-a-shot/comment-page-1/#comment-14528 CMCguy Thu, 11 Jun 2009 21:46:51 +0000 http://blog.pharmtech.com/?p=1403#comment-14528 I think shared audits are a good idea and would take it a step further by establishing core audit teams made up from combining the different agencies, companies and third-parties (consultants and others) into cross functional groups (expanded ICH like collaboration). Having multiple perspectives and expertise's involved is likely to generate greater benefits plus more balance then any single entity auditors. I don't know much about the actual workings but could ISO type Certification serve as model or even a centralized platform? I know from experience there are significant differences in GMP vs ISO however there are also common elements. Establishing process for "GMP-Certified" Suppliers may not get rid of all issues but would provide a base-line or foundation. I do understand need to keep certain specific details from competitors however should be able to provide general or higher level summaries that elude to competences and areas to watch/develop in a particular supplier. Anything that is implemented will have to contain monitoring and recertification so companies do not remain static as continuous improvements required. I think shared audits are a good idea and would take it a step further by establishing core audit teams made up from combining the different agencies, companies and third-parties (consultants and others) into cross functional groups (expanded ICH like collaboration). Having multiple perspectives and expertise’s involved is likely to generate greater benefits plus more balance then any single entity auditors.

I don’t know much about the actual workings but could ISO type Certification serve as model or even a centralized platform? I know from experience there are significant differences in GMP vs ISO however there are also common elements. Establishing process for “GMP-Certified” Suppliers may not get rid of all issues but would provide a base-line or foundation. I do understand need to keep certain specific details from competitors however should be able to provide general or higher level summaries that elude to competences and areas to watch/develop in a particular supplier. Anything that is implemented will have to contain monitoring and recertification so companies do not remain static as continuous improvements required.

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