Pharmaceutical Technologist - September/October 2008 - (Page 6)

Editor’s comment Are you Qualified? R ecently, I have developed an interest in Qualified Persons (QPs). By this, I don’t mean QPs as in ‘persons with a qualification’, but ‘persons that hold the QP legal status’. The legal basis for a QP was first defined in November 2001 by the European Parliament on the Community code relating to medicinal products for human use. This states that a QP shall possess a diploma, certificate or other evidence of formal qualifications awarded after completing a university course, extending at least 4 years, of theoretical and practical study in pharmacy, medicine, chemistry, pharmaceutical chemistry and technology, or biology. Additionally, the QP must have acquired practical experience of at least 2 years in one or more activities authorized to manufacture medicinal products, and that involve the analysis and necessary testing of active substances and medicinal products to ensure their quality. Interestingly, in true European style, the prerequisites to becoming a QP are slightly different in each Member State, resulting in some confusion for those looking to offer their services internationally or hoping to relocate. For example, in Germany, regulatory authorities are stricter and require a QP to be a pharmacist, while in other Member States chemists and biologists can also qualify for the position. A similar situation can be observed in France, where a ‘Pharmacien Responsible’ (the French denomination for a QP) must be a qualified pharmacist registered in France. However, there is also a strong determination to achieve harmonization, and Member States have shown exemplary behaviour in attempting to iron out differences and facilitate the flow of QPs from country to country. Consequently, although one as a chemist would not be eligible as a QP in Germany, a compromise has been reached where a chemist would be accepted once he/she is registered as a QP in another Member State. What is the purpose or role of a QP and how do they fit within the manufacturing process? Primarily, QPs fulfil a quality management function. Each holder of a manufacturing organization is required to have at least one designated QP who is responsible for guaranteeing that each batch of product manufactured by the organization in the Member State where it is based has been produced and tested in compliance with the laws enforced in the Member State and the requirements of the marketing authorization. So, if this is the job for you and you are hoping to become a QP, in addition to the qualifications and experience stated previously, you'll need to register in the Member State where the company resides and you'll have to have been named by the holder of the marketing authorization. Conversely, if you are the holder of a manufacturing organization and are looking to secure the services of a QP then you'll need to designate one and/or inform the relevant authorities, as it is the Member States’s responsibility to ensure that any such organization has the services of at least one QP at their disposal permanently and continuously. 6 SEPTEMBER/OCTOBER 2008 PHARMACEUTICAL TECHNOLOGIST

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - September/October 2008

Pharmaceutical Technologist - September/October 2008 Contents Industry Highlights Morpheus Market Watch Smoke and Mirrors Reducing Data Burdens Keeping it Simple Bringing Pharma Up to Date

Pharmaceutical Technologist - September/October 2008

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