Quality management, Good

EU GMP Chap. 1 on Pharmaceutical Quality System highlights the inter-relation of the basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management and emphasises their fundamental importance to the production and control of medicinal products. 

TQM involves all the organizations, all the functions, the external suppliers, the external customers and involves the quality policy. Similarly, TQM cannot be achieved without good Quality Management Systems (QMS) which bring together all functions relevant to the product, providing policies, procedures and documentation. The elements of a quality organization consist of these three mutually dependent items (Field and Swift, 1996) ... 

All group working sessions should be led by someone with a strong background in Quality Management and good facilitation skills. It is important that these individuals have the ability to draw out ideas from the team without imposing their own ideas. These facilitators need not be full-time members of the team, but are called upon when needed. 

Managers with good experience of other Quality Management initiatives are likely candidates for active support. 

A common concern expressed by managers is that PSM and ESH are costs to their operations that adds little or nothing to customer satisfaction. The use of quality management approaches should ensure that the new systems will be more efficient and so costs will actually fall. It may also be possible to demonstrate that facilities with excellent PSM and ESH records have good performance in other areas. You should look for such examples within your own organization. 

The top management of the organization produces the quality policy. This sets out the overall objectives of the quality management system. It should include reference to the management s commitment to good professional practice, compliance with the quality standard, and a framework for establishing and reviewing quality objectives. 

Raspberries are usually sold as bareroot plants for winter planting. It is essential to buy certified virus-free stock from a reputable supplier. Well-managed, good-quality stock will crop for up to 14 years if grown in acidic soil. 

The principles of Good Laboratory Practice (GLP) in conjunction with the principles of Total Quality Management (see chapter 6) ensure the quality and reliability of the laboratory results, which in turn help to ensure the protection of the environment and human health and safety. A step further is the accreditation of laboratories to ISO 17025 (see chapter 2) to perform specified activities. 

Good Laboratory Practice is a quality system that is tailored to the needs of the modem laboratories. Its principles are very close to the principles of the modem quality management systems like ISO 9000 and ISO 17025. However, GLP is specific to the non-clinical health and environmental safety studies, it covers physical and chemical test systems, and gives emphasis to biological test systems. It is of utmost importance to note that GLP principles were set out by the Organization for Economic Cooperation and Development (OECD) and after being modified they were adopted by the Emopean Union and are now the Commission Directive 1999/11/EC. 

Total Quality Management (TQM) is a eompany enltnre that allows it to provide qnality goods and services at the lowest cost in order to achieve cnstomers satisfaction and, at the same time, ensnre satisfactoiy business development by continuous improvements. The definition of TQM shown in this shde is taken from the British Standard 7850. 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

Because volumes are devoted to the statistics of data analysis in the analytical laboratory (indeed, I recently authored one [Hibbert and Gooding 2005]), I will not rehearse the entire subject here. Instead, I present in this chapter a brief overview of the statistics I consider important to a quality manager. It is unlikely that someone who has never been exposed to the concepts of statistics will find themselves in a position of QA manager with only this book as a guide if that is your situation, I am sorry. 

Continuous quality improvement (CQI) is aphilosophy of continual improvement of the processes associated with providing a good or service that meets or exceeds customer expectations (Shortell et al., 1998). CQI, which was first employed in the manufacturing field, was introduced into health care by Berwick and Leape (1999). [CQI has been referred to as quality improvement process, total quality management, and total quality control (Lohr, 1990b).]... 

Final Good Manufacturing procedure / Quality Management System audit... 

EC (1998b), Quality management, In The Rules Governing Medicinal Products in the European Union, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, vol. 4, Eudralex. Available at http //pharmacos.eudra.org/ F2/eudralex/vol-4/pdfs-en/caplen.pdf (accessed October 2006). 

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