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International GMPs

Quality Management and the Qualified Person

Due to the nature of its legislation, the United States holds the senior most member of management directly, and personally, responsible for any infractions of, or breaches in compliance with the GMPs. It is the President or the Managing Director that is the person that could go to jail if adulterated product, product not complying with the GMPs, is marketed.

In Europe, deriving from the French legislation and the recognition that there is a Responsible Pharmacist (le Pharmacien Responsible), and from Italian legislation holding the company’s Technical Director personally responsible for infractions of GMP, the EU has evolved the role of the Qualified Person (the “QP”) within a company as the person who is directly and legally responsible for ensuring that the pharmaceutical product is manufactured according to the manufacturing and quality testing (GMP) commitments made by the company to the authorities in its application to market the product.  In the EU it is the QP that could go to jail if adulterated product is marketed.

The QP is required to have the necessary basic scientific and technical background and experience, including a University Degree from an EU Member State with a minimum of 4 years theoretical/practical studies in Pharmacy, Veterinary medicine, Chemistry or Biology; and have a minimum of 2 years experience working in the industry (very different from the United States where it is very rare to find a pharmacist working in manufacturing or quality control). In some EU countries becoming a QP also requires passing examinations set by either the national authority or by professional organizations acting on behalf of the national health agencies as the QP registration agencies.

The QP must certify, by transcription on a register, before release, that each batch meets the requested conditions, and that:

  • GMPs have been followed in all aspects of manufacture;
  • records are traceable and are archived;
  • manufacturing and testing processes have been validated;
  • and that any changes or deviations in manufacturing/packaging and quality control testing from that in the product license and will be notified to the Authorities.

Although the US approach to GMPs enforcement does not ‘in words’ discuss the role and responsibilities of a function such as that of the “QP”, in effect such a role is that of the Quality Assurance function as practiced in American pharmaceutical companies.

 
   
   

 

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