(1999; 168 pages) [Spanish]
5.1 Adoption of additional guidelines
The Committee adopted two supplements to the GMP guidelines published as Annex 1 to its thirty-second report (8); these texts provide additional advice on the role, functions and training of the "authorized person" (Annex 4), and on the manufacture of pharmaceutical excipients (Annex 5). In adopting the guidelines on the authorized person, the Committee emphasized that this text did not represent additional requirements in the area of GMP. It was offered as advice to manufacturers wishing to strengthen their existing quality assurance systems.