Quality Assurance and Good Laboratory Practice

This chapter introduces the tools available to ensure the quality of analytical-chemical measurement. It helps to learn about regulatory and legal aspects of quality assurance and quality control. Validation describes in general the assurance that an analytical procedure provides reproducible and secure results that are required for the application intended. An analytical laboratory proves its effective quality assurance system by accreditation. Accreditation attests to the competence of a laboratory for performing given analytical methods versus an independent customer. The Commission of the European Union has harmonized the national accreditation systems. Unique criteria were developed for the operation of the test laboratories and for their accreditation and certification. The chapter also explores the concept of good laboratory practice (GLP). GLP is mainly concerned with assuring the repeatability of investigations. The assurance of quality is guaranteed in the system by an additional quality assurance unit that is controlled by continuous inspections to maintain the principles of GLP.