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Abstract

Interactions between areas governed by good laboratory practice (GLP), good clinical practice (GCP), and good manufacturing practice (GMP) regulations become increasingly important in drug development. A common quality system addressing requirements of these regulations and arranged to recommendations of ISO 9000 standards could be helpful to facilitate cooperation and to avoid redundancy. An unexpected obstacle to the development of such a quality system is the divergent use of quality-related terminology in the various “good practice” source documents. The present paper tries to raise awareness of this problem and makes an attempt to offer solutions. Preferential use of terms described in ISO 8402 is suggested as well as the use of qualifying terms, including reference to the specific regulation addressed. While harmonization of quality-related terminology between different areas in drug development is highly desirable, the suggested use of terms should allow unequivocal communication, and the development of a common quality system.

Keywords

Good laboratory practice Good clinical practice Good manufacturing practice ISO 8402 Terminology

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References

Organisation for Economic Co-operation and Development (OECD). Good Laboratory Practice in the Testing of Chemicals. Final Report of the group of experts on Good Laboratory Practice. Paris, 1982.

OECD. “Guides for Compliance Monitoring Procedures for Good Laboratory Practice.” In: Council Decision of July 28, 1989 on the acceptance by the European Economic Community of an OECD decision/recommendation on compliance with principles of good laboratory practice (89/569/EEC). OJ No L315/1 of 28, October 1989.

Code of Federal Regulations. Office of the Federal Register, Title 21, revised as of April 1, 1993. 21 CFR 58: Good laboratory practice for nonclinical laboratory studies.

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Code of Federal Regulations. Office of the Federal Register, Title 21, revised as of April 1, 1993; (a) 21 CFR 50: Protection of human subjects. Subpart B —Informed Consent of Human Subjects; (b) 21 CFR 56: Institutional review boards; (c) 21 CFR 312: Investigational new drug application. Subpart D — Responsibilities of Sponsors and Investigators.

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Code of Federal Regulations. Office of the Federal Register, Title 21, revised as of April 1, 1993; (a) 21 CFR 210: Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general; (b) 21 CFR 211: Current good manufacturing practice for finished pharmaceuticals.

(a) DIN ISO 9000. Quality management and quality assurance standards—Guidelines for selection and use; (b) DIN ISO 9001. Quality systems—Model for quality assurance in design/development, production, installation and servicing; (c) DIN ISO 9004. Quality management and quality system elements —Guidelines. German-English-French edition. Beuth Verlag, Berlin; 1990.

DIN ISO 8402 (Draft). Quality management and 2ality assurance; vocabulary. German-English edition. Beuth Verlag, Berlin; 1992.

10.

Juran

Gryna

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