Institute of Quality Assurance

Audits are usually conducted by an audit team and led by a qualified, accredited auditor. Accredited auditors should have completed a certified development program, be accredited under an appropriate standard (ISO 9000 2000 TicklT in this context), and should have conducted a number of qualifying audits. Pharmaceutical and healthcare companies that do not have their own accredited auditors can engage an independent auditor, as we have seen. Names and addresses of accredited auditors can be found in national registers of certified auditors. The International Register of Certificated Auditors is one such register, associated with the Institute of Quality Assurance (IQA). 

U.K. IQA (1994) Pharmaceutical Supplier Code of Practice Covering the Manufacturing of Pharmaceutical Raw Material, Active Ingredients and Excipiants, Document Reference No. P00020, Issue 2, Institute of Quality Assurance, Pharmaceutical Quality Group. 

Pharmaceutical Supplier Code of Practice (obtained via Institute of Quality Assurance, London.) (i) The manufacture of printed materials for use in the packaging and labelling of medicinal products (document reference P00021). (ii) The manufacture of medicinal product contact packaging materials (document reference P00022). 

Use ISO 9000 registered suppliers especially those used to dealing with pharmaceutical printing. Codes of practice are issued by the Pharmaceutical Quality Group of the Institute of Quality Assurance and linked to ISO 9002, specifically aimed at printing suppliers to the industry. 

Note In the UK the Pharmaceutical Quality Group (Institute of Quality Assurance) have devised Supplier Codes of Practice which link GMP to ISO 9002 Quality System certification. 

Pharmaceutical Supplier—Code of Practice (UK), The Manufacture of Pharmaceutical Raw Materials (British Standard Institute of Quality Assurance—Pharmaceutical Group). 

RAL-German Institute for Quality Assurance and Certification (2006) Basic criteria for the award of the environmental label. Office printing devices RAL-UZ-122. St. Augustin, Germany. 

Radiation processing plays an important role in industry, health care, agriculture and environmental technology. It involves the use of large radionuclide (gamma-radiation) sources and electron accelerators in industrial and institutional facilities. Quality assurance is vital for the success of this technology. In fact, it is indispensable for... 

J. K. Taylor, Principles of Quality Assurance of Chemical Mea.surements. NBSIR 85-3105. National Institute of Standards and Technology, Gaithersburg, MD, USA, 1985b, p. 71. 

Inspections are not just an exercise which Quality Assurance performs for its own sake. Since it is the task of Quality Assurance to ensure the maintenance of GLP compliance, it is obvious that any deviations from the rules of GLP that are observed in these inspections should be corrected. Inspection reports therefore serve the dual function of permitting test facility management to judge the functioning of the Quality Assurance itself, and of permitting test facility management and Study Directors alike to institute the measures deemed necessary for a full and continued adherence to the GLP Principles. 

COST Action B3 (1992-1997) was devoted to the development of new radiotracers for nuclear medicine application and methods of quality assurance. National institutions of sixteen European states participated in five Working Groups (WG). 

International partnerships, networking of institutions, harmonization of quality assurance, and accreditation systems and processes are becoming the concern of institutions across the world. There is intense activity worldwide in disseminating and sharing knowledge and experience of different countries and institutions. 

The detection sensitivity of radiography is related among others to the properties and quality of industrial x-ray film systems. Changes of the products, variations due to different emulsions and combinations of products of different manufacturers can influence the decisive properties of film systems as classified in EN 584-1.To ensure the quality of industrial x-ray film systems a system for quality assurance open to all interested parties is proposed which is based on periodical round robin tests and quality controls of the manufacturer or an independent third party institution. 

Fig. 14-9. Wet/dry precipitation collector and flow chart for analysis of samples. (DI HjO distilled water). Source "NADP Quality Assurance Report," Central Analytical Laboratory, Illinois Institute of Nafural Resources, Champaign, 111., March 1980.

KN Lohr, ed. Institute of Medicine, Medicare A Strategy for Quality Assurance. Vol. 1. National Academy Press, 1990. 

Arvanitoyiannis I, Hadjicostas E (2001) Quality Assurance and Safety Guide for the Food and Drink Industry CIHEAM/Mediterranean Agronomic Institute of Chania / European Commission MED A... 

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