The NHS quality agenda and the role of the quality assurance pharmacist

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Chapter: Hospital pharmacy : Quality assurance

QA of pharmaceutical products and services is of prime importance. Patients rely on pharmacists providing medicines which are consistently safe, efficacious and of suitable quality.


The NHS quality agenda and the role of the quality assurance pharmacist

 

Quality assurance

 

QA of pharmaceutical products and services is of prime importance. Patients rely on pharmacists providing medicines which are consistently safe, efficacious and of suitable quality. Quality itself has a number of definitions: dictionary.com has 19 different definitions for quality, many of which give a rather subjective view, one which is both comparative and difficult to quantify and measure. The total quality management (TQM) approach describes quality as: ‘meeting customer needs’. TQM is a management philosophy which embraces all activities, through which the needs and expectations of the customer and the community are satisfied, and through which the object-ives of the organisation are met; these aims are achieved in the most cost-effective way by maximising the potential of all employees in a continuing drive for improvement. This is a useful definition to apply to pharmacy services, and one that aims to ensure service objectives are entirely organised around meeting customer needs.

 

A third approach to defining quality, and the one most appropriate to be applied to pharmaceutical products, is the ‘fitness for purpose’ definition, as adopted in pharmaceutical manufacturing over many years. The Rules and Guidance for Pharmaceutical Manufacturers and Distributors (com-monly called the Orange Guide because of the colour of its cover) states that the quality objective in manufacturing is to ensure that the products are ‘consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification’. This definition can be applied in a quantitative sense, with quality parameters and limits being set against which all services or batches of products are tested and checked for compliance. Examples of this are product specifications comprising assays and service specifications comprising quantitative service parameters, such as length of waiting times for prescriptions.

 

‘Quality assurance’ is the term applied to all the arrangements which influence the quality of the products or services supplied. The Orange Guide defines it as ‘the total sum of the organised arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use’. In pharmaceutical manufacturing it encompasses both good manufacturing practice (GMP) and QC. GMP is the part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. QC is the part of GMP concerned with sampling, specifications and testing, and with the release of products for use. Sharp provides a detailed discussion of these concepts in his text on quality in manufacture of healthcare products.

 

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