Qualified Person pharmacies

Cold kits may also be prepared in a radiopharmacy similar to other medicinal products prepared in a pharmacy. The radiopharmacist then functions as the qualified person responsible for preparation of an official formula (formulation, pharmaceutical requirements, stability, etc.)... 

The fields of manufacture, control and distribution have been loaded with GMP and GDP related regulations and recommendations in order to minimise errors. These regulations require a Qualified Person (QP), or Responsible Person or Authorised Person to be involved before the product is admitted to the market. Adverse event monitoring and reporting have been subject to pharmacovigilance regulations, supervised by a Qualified Person for Pharmacovigilance (QPPV). These developments in industiy have in their turn increased attention and requirements to similar functimis in preparation in conununity and hospital pharmacies. 

The final release of products comprises a major responsibility, which must be independent of production. In pharmaceutical industry release is performed by a qualified person (QP), in pharmacies often by a pharmacist. Investigational medicinal products (IMPs) always have to be released by a notified QP (Sect. 25.3.4). 

Qualified Person. So a hospital pharmacy needs a QP (see Sect. 25.3.4) for this functionality. 

The EU Directive [3] introduced the concept of an individual taking responsibility for releasing a batch of product to market. This position, uifique to Europe, is defined by the Qualified Person. This individual has to take decisions independent fi om the Board. The role is further elaborated on in the Guide to GMP (see also Sect. 25.3.4). This role is only defined for products with a Marketing Authorisation and Investigational Medical Products. However the function is equally applicable to preparations made by the pharmacist. Pharmacies should nominate a person, independent of the preparation function, to be responsible for the release of the preparation. 

According to the law of Uganda, a medicine should never be dispensed in a retail pharmacy if the authorized person is absent. But given Uganda s low number of qualified pharmacists, this requirement is not met anywhere in the country other than in the capital, Kampala. Moreover, many of Uganda s dmg shops, particularly those in mral areas, are neither licensed nor operated by medically trained personnel, and some dmg shop premises are in poor condition. 

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