CMO
• If the internal QA function lacks the required level of expertise, to conduct a thorough vendor selection and qualification process, contracting external auditors with the required level of expertise is worth the investment
• Make sure that the contract undergoes thorough QA review • Risk of drug/project failure is assumed by the contracting company
• The size/capacity of the provider to be selected should be of a caliber that can accommodate any potential growth of the initial project
The failure of a CRO/CMO to comply with the law or to deliver on contracted services translates to a failure of the sponsor to both comply and deliver.
References
1. Toronto D. Selecting the optimal CMO for your business critical screening steps. Available at:
http://sennchem.com/sennchem_wp/wp-content/uploads/2014/03/resources_ Selecting_the_Optimal_CMO_Jan_2013.pdf. Accessed February 14, 2015.
2. Mansell P. Pharma outsourcing over one third of trials. Clin News. December 22, 2011.
3. 2014 Annual Outsourcing Survey. Contract Pharma. May 11, 2014. Available at: http://
www.contractpharma.com/contents/view_outsourcing-survey/2014-05-11/2014-annual- outsourcing-survey. Accessed February 15, 2015.
4. Langer S. Survey Examines Trends in the outsourcing relationship. Biopharm International. Available at:
http://www.biopharminternational.com/survey-examines-trends- outsourcing-relationship. Accessed on February 12, 2015.
Amer Alghabban has over a 24-year track record in the pharmaceutical industry (GxP QA, Development, Pharmacovigilance, and Medical Communications). For some time, he was the Assistant Editor for 11 medical and pharmaceutical journals. He contributed further to these disciplines by writing The Pharmaceutical Medicine Dictionary book in April 2001 and The Dictionary of Pharmacovigilance in May 2004, and is currently writing his third book, Dictionary of Clinical & Pharmaceutical Development. Amer presented and chaired at over 65 international congresses, universities, and WHO. He is currently the Managing Director of GxP Compliance and Training Partners (GCTP) and a consultant for several pharma and CRO companies.
5. Glass HE, Beaudry DP. Key factors in CRO selection. Applied Clinical Trials. April 1, 2008.
6. Contract Manufacturing Strategies: Market developments, technology transfer and key success factors. Business Insight. Available at:
http://www.chidb.com/business_insight/ descriptions/
contact_manufacturing.asp. Accessed February 12, 2015.
7. Strauss M, Novak J. Selection and oversight of domestic and international CMOs. BioProcess International. March 2009.
8. Pharma IQ (Division of IQPC). How pharmaceutical companies will pick their contract manufacturing organizations in 2012. IQPC survey conducted Nov 2011. Pharmaceutical Online. March 26, 2012. Available at:
http://www.pharmaceuticalonline.com/doc/how- pharmaceutical-companies-will-pick-their-0001. Accessed February 12, 2015.
9. Pharmaceutical quality system Q10 current step 4 version. June 4, 2008. 10. ISO 9001:2000 - Quality management systems – Requirements.
11. Master Control- White Paper: How to successfully manage your suppliers and ensure product safety and compliance. Available at:
http://proddownloads.vertmarkets.com.
s3.amazonaws.com/download/9dd2c916/9dd2c916-74cf-4879-a07b-d93453b25855/ original/mc_w_supplier_management.pdf. Accessed February 12, 2015.
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eClinicalOS.com pharmoutsourcing.com | 21 | March/April 2015
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