(1999; 168 pages) [Spanish]
Annex 4. Good manufacturing practices: authorized person - role, functions and training
This text does not constitute additional requirements in the area of good manufacturing practices (GMP). It is intended to assist manufacturers wishing to strengthen their quality assurance systems. References to ISO standards of the 9000 series are relevant primarily to manufacturers not in a position to implement full GMP requirements immediately. The reason for this may be lack of resources or a limited involvement in contractual manufacturing/testing of drugs. For such manufacturers/testing laboratories, the implementation of quality systems along the lines of ISO standards will be a step in the right direction. Manufacturers fully complying with GMP requirements may wish to adopt on a voluntary basis certain elements found in ISO standards of the 9000 series, e.g. quality manuals. Nothing in this text should be interpreted as a suggestion that drug manufacturers need external certification under ISO standards.
The GMP guidelines published by WHO1 define the authorized person as a person (among key personnel of a manufacturing establishment) responsible for the release of batches of finished products for sale. In some other GMP guides and legal texts the term qualified person is used to describe analogous functions.
1 Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).