Quality Assurance Ian M Beaumount

National health Service (NHS) regional quality control (QC) laboratories were first established in 1966 following Health Memorandum HM (65)22 [1]. This dealt with the QC of purchased drugs and dressings, giving guidance to NHS regions on setting up regional QC services. The aim was to ensure that the quality of the products purchased through the regional purchasing system met a satisfactory standard. In the early 1970s the work of laboratories was significantly extended following HSC (IS) 128 Application of the medicines act to health authorities, which applied the principles of the medicines act to all pharmaceutical manufacturing operation undertaken by health authorities [2]. This required quality assurance (QA) and QC arrangements to be in place for all such activities and resulted in provision of QC laboratory facilities for each NHS manufacturing unit, located in most major pharmacy departments. It also resulted in them being subjected to regular inspection by the medicines inspectorate [3,4]. In 1984, Health circular HC(84) 3 introduced a policy of costing hospital pharmaceutical manufacturing operations and required the NHS to engage in manufacture only if there was no satisfactory commercial source or if it was significantly more economical to do so [5]. This, along with the increasing commercial availability of hospital requirements, resulted in the rationalization of both manufacturing and QC laboratory facilities through the remainder of the 1980s and the 1990s. Some NHS regions took the view that QA and QC services should be provided centrally at regional level, in order to make the best and most cost-effective use of the specialist staff and laboratory resources; this result in regional QC services based within one or two large laboratories on hospital sites within their region. In recent years there has been (and continues to be) a very large increase in the number of pharmacy aseptic units preparing injections and other product, as well as an increase in the preparation of clinical trials materials. NHS Executive Letter EL(96) 95 and EL(97)52 [6, 7] introduced requirements for regular internal and external quality audit of pharmacy aseptic preparation activities. The requirements established the role of the regional QA specialist in performing these external audits. These aseptic services, along with the remaining NHS manufacturing units, continue to require specialist QA and QC facilities as well as pharmacist and other QA staff with substantial skills and knowledge in QA, good pharmaceutical manufacturing practice, QC, audit, pharmaceutical sciences and technology, formulation and stability.

The NHS quality agenda and the role of the quality assurance pharmacist Quality Assurance The assurance of quality in 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 the Concise Oxford Dictionary defines quality as degree of excellence, relative nature or kind of character [8]: This implies a rather subjective view of quality comparative and difficult to quantify and measure. The total quality management (TQM) approach describes quality as meeting customer needs [9]. 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 objectives of the organization are met; these aims are achieved in the most cost-effective way by maximizing the potential of all employees in a continuing drive for improvement. This is appropriate for pharmacy services, and aims to ensure that the service objectives are entirely organized around meeting customer needs. A third approach to defining quality, and one which is 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 (commonly 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 fit for their intended use [10]. 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 assay and services specifications comprising quantitative service parameters such as length of waiting times for prescriptions. Quality assurance is the term applied to all the arrangements which influences the quality of the products or services supplied. The Orange Guide defines it as the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use [10]. In pharmaceutical manufacturing it encompasses both good manufacturing practice (GMP) and QC. GMP is the part of QA which ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use. QC is the part of GMP concerned with the sampling, specifications and testing, and with the release of products for use. Sharp provides a details discussion of these concepts in his text on quality in manufacture of health care products [11]. Clinical governance