Outsourcing: What Has to Be Taken into Account from a GMP Perspective?

GMP News
4 October 2007
 

Outsourcing:
What Has to Be Taken into Account from a GMP Perspective?

 
The tendency to have individual manufacturing steps or even the complete production of a medicinal product carried out by a suitable contract manufacturer continues unbroken. There are many reasons for this:

  • A lack of resources in the respective manufacturing technology (special dosage forms)
  • Capacity bottlenecks
  • The fear that equipment and personnel will not be working to capacity when a new product is introduced
  • Focussing on marketing
  • No or insufficient manufacturing licence

Therefore, the production itself is often not among the core competencies of a pharmaceutical company any more. The customer makes use of the competence and flexibility of the service provider. However, price and above all quality must be right - apart from the pharmaceutical quality, this also refers to delivery reliability and service. The process of building up the customer-supplier relationship should begin before the transfer itself takes place. That will then be a decisive step in establishing a working partnership. Those suppliers who demonstrate that they are competent in this area often have an advantage over the mostly lower-price competitors abroad. A good all-round service also includes the necessary product advice and the pharmaceutical documentation. The scope of the service is laid down in appropriate contracts.

A study by the US-American Universities of St. Louis and Georgetown, brought into being under the name of Pharmaceutical Research Manufacturing Project (PRMP) and with the support of FDA in 2002, also includes interesting data on outsourcing. We have already reported about the results, which were published for the first time in September 2006. The study's comprehensive data collection includes among others information on problems observed in contract manufacturing. Some of the data show that problems can occur time and again within the framework of contract manufacturing: There is e.g. evidence of a statistically significant number of failed batches. Furthermore, difficulties existed in the form of lower yield and longer throughput times. However, it was also recorded that the number of deviations decreased over the time of contracting. This can be interpreted as an indication of how important it is to continuously foster the relationship between customer and contractor.

With regard to inspections, deficiencies occur mainly in auditing and contract creation. In the period 2005/2006 e.g. critical major deviations of this kind ranked 7th in the list of frequent observations by the British supervisory authority MHRA in the United Kingdom.

The complete PRMP report can be found here: http://www.olin.wustl.edu/faculty/nickerson/results/PMRPFinalReportSept2006.pdf
 

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Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
 

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